Intra-Cellular Therapies Annual Report 2015

Plain-text annual report

INTRA-CELLULAR THERAPIES, INC. FORM 10-K (Annual Report) Filed 02/25/16 for the Period Ending 12/31/15 Address Telephone CIK Symbol SIC Code Fiscal Year 430 EAST 29TH STREET NEW YORK, NY 10016 212-923-3344 0001567514 ITCI 2834 - Pharmaceutical Preparations 12/31 http://www.edgar-online.com © Copyright 2016, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use. Table of Contents UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K (Mark One)xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2015OR ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to Commission file number: 001-36274 Intra-Cellular Therapies, Inc.(Exact name of registrant as specified in its charter) Delaware 36-4742850(State or other jurisdiction ofincorporation or organization) (I.R.S. EmployerIdentification No.)430 East 29th StreetNew York, New York 10016(Address of principal executive offices) (Zip Code)Registrant’s telephone number, including area code (212) 923-3344Securities registered pursuant to Section 12(b) of the Exchange Act: Title of each class Name of each exchange on which registeredCommon Stock, $0.0001 Par Value Per Share The NASDAQ Global Select MarketSecurities registered pursuant to Section 12(g) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No xIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ¨ No xIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days. Yes x No ¨Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submittedand posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post suchfiles). Yes x No ¨Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’sknowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of“large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer x Accelerated filer ¨Non-accelerated filer ¨ [Do not check if a smaller reporting company] Smaller reporting company ¨Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No xThe aggregate market value of the registrant’s voting and non-voting common stock held by non-affiliates of the registrant (without admitting that any person whose sharesare not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last business day of the registrant’s mostrecently completed second fiscal quarter was $750.7 million.As of February 25, 2016, the registrant had 43,212,709 shares of common stock outstanding. Table of ContentsTABLE OF CONTENTS Page PART I 4 Item 1. Business 4 Item 1A. Risk Factors 29 Item 1B. Unresolved Staff Comments 52 Item 2. Properties 52 Item 3. Legal Proceedings 52 Item 4. Mine Safety Disclosures 52 PART II 53 Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities 53 Item 6. Selected Financial Data 55 Item 7. Management’s Discussion And Analysis Of Financial Condition And Results Of Operations 56 Item 7A. Quantitative And Qualitative Disclosures About Market Risk 71 Item 8. Financial Statements And Supplementary Data 71 Item 9. Changes In And Disagreements With Accountants On Accounting And Financial Disclosure 71 Item 9A. Controls And Procedures 71 Item 9B. Other Information 73 PART III 74 Item 10. Directors, Executive Officers And Corporate Governance 74 Item 11. Executive Compensation 74 Item 12. Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters 74 Item 13. Certain Relationships And Related Transactions, And Director Independence 74 Item 14. Principal Accounting Fees And Services 74 PART IV 75 Item 15. Exhibits, Financial Statement Schedules 75 Signatures 79 2Table of ContentsDOCUMENTS INCORPORATED BY REFERENCEThe following documents (or parts thereof) are incorporated by reference into the following parts of this Form 10-K: Certain information required in Part IIIof this Annual Report on Form 10-K is incorporated by reference from the Registrant’s Proxy Statement for the 2016 Annual Meeting of Stockholders to be filedwith the Securities and Exchange Commission. 3Table of ContentsPART IAll brand names or trademarks appearing in this report are the property of their respective holders. Use or display by us of other parties’ trademarks, tradedress, or products in this report is not intended to, and does not, imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dressowners. Unless the context requires otherwise, references in this report to the “Company,” “we,” “us,” and “our” refer to Intra-Cellular Therapies, Inc. and itswholly-owned subsidiary, ITI, Inc. Item 1.BUSINESSOverviewWe are a biopharmaceutical company focused on the discovery and clinical development of innovative, small molecule drugs that address underservedmedical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. ITI-007 isour lead drug development candidate with mechanisms of action that, we believe, may represent an effective treatment across multiple therapeutic indications. Inour pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, orDPPM, glutamatergic modulation, and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia and thetreatment of bipolar disorder, including bipolar depression. At dopamine D2 receptors, ITI-007 has been demonstrated to have dual properties and to act as both apre-synaptic partial agonist and a post-synaptic antagonist. ITI-007 has also been demonstrated to have affinity for dopamine D1 receptors and indirectly stimulatephosphorylation of glutamatergic NMDA GluN2B receptors in a mesolimbic specific manner. We believe that this regional selectivity in brain areas thought tomediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, and dopaminergic interactions, may result in efficacy for a broad array ofsymptoms associated with schizophrenia and bipolar disorder with improved psychosocial function. The serotonin reuptake inhibition potentially allows forantidepressant activity in the treatment of schizoaffective disorder, other disorders with co-morbid depression, and/or as a stand-alone treatment for majordepressive disorder. We believe ITI-007 may also be useful for the treatment of other psychiatric and neurodegenerative disorders, particularly behavioraldisturbances associated with dementia, autism, and other CNS diseases. ITI-007 is in Phase 3 clinical development as a novel treatment for schizophrenia andbipolar depression.ITI-007 for the Treatment of SchizophreniaIn September 2015, we announced top-line clinical results from our first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia.This randomized, double-blind, placebo-controlled Phase 3 clinical trial was conducted at 12 sites in the United States with 450 patients randomized (1:1:1) toreceive either 60 mg of ITI-007, 40 mg of ITI-007 or placebo once daily in the morning for 28 days. The pre-specified primary efficacy measure was change frombaseline versus placebo at study endpoint (4 weeks) on the centrally rated Positive and Negative Syndrome Scale, or PANSS, total score. In this trial, the once-dailydose of 60 mg of ITI-007 met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at week 4 (studyendpoint) with additional improvements observed in social function. Moreover, the 60 mg dose of ITI-007 showed significant antipsychotic efficacy as early asweek 1, which was maintained at every time point throughout the entire study. ITI-007 showed a dose-related improvement in symptoms of schizophrenia with the40 mg dose approximating the trajectory of improvement seen with the 60 mg dose, but the effect with 40 mg did not reach statistical significance on the primaryendpoint. In addition, the 60 mg dose of ITI-007 met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scalefor Severity of Illness, or CGI-S. The 40 mg dose of ITI-007 also demonstrated a statistically significant improvement versus placebo on the CGI-S, though notformally tested against placebo as a key secondary endpoint since it did not separate on the primary endpoint. Consistent with previous studies, ITI-007 had afavorable safety and tolerability profile as evidenced by motoric, metabolic, and cardiovascular characteristics similar to placebo, and no clinically significantchanges in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin, or lipids. 4Table of ContentsIn September 2015, we also announced top-line data from an open-label positron emission tomography, or PET, study of ITI-007 examining brain occupancyof striatal D2 receptors. This study was conducted in patients diagnosed with schizophrenia who were otherwise healthy and stable with respect to their psychosis.After washout from their previous antipsychotic medication for at least two weeks, PET was used to determine target occupancy in brain regions at baseline (drug-free) and again after two weeks of once daily ITI-007 oral administration. In this trial, the 60 mg dose of ITI-007 was associated with a mean of approximately 40%striatal dopamine D 2 receptor occupancy. As predicted by preclinical and earlier clinical data, ITI-007 demonstrated antipsychotic effect at relatively low striatal D2 receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. Unlike any existing schizophrenia treatment, this dopaminereceptor phosphoprotein modulator, or DPPM, acts as a pre-synaptic partial agonist and post-synaptic antagonist at D 2 receptors. We believe this mechanism likelycontributes to the favorable safety profile of ITI-007, with reduced risk for hyperprolactinemia, akathisia, extrapyramidal symptoms, and other motoric side effects.The top-line results from our first Phase 3 clinical trial of ITI-007 confirm the earlier Phase 2 results that we announced in December 2013, in which ITI-007exhibited antipsychotic efficacy in a randomized, double-blind, placebo and active controlled clinical trial in patients with an acutely exacerbated episode ofschizophrenia. In this Phase 2 trial, 335 patients were randomized to receive one of four treatments: 60 mg of ITI-007, 120 mg of ITI-007, 4 mg of risperidone(active control) or placebo in a 1:1:1:1 ratio, orally once daily for 28 days. The primary endpoint for this clinical trial was change from baseline to Day 28 on thePANSS total score. In this study, ITI-007 met the trial’s pre-specified primary endpoint, improving symptoms associated with schizophrenia as measured by astatistically significant and clinically meaningful decrease in the PANSS total score. The trial also met key secondary outcome measures related to efficacy onPANSS subscales and safety. We are also conducting a second Phase 3 clinical trial in schizophrenia that we initiated in the second quarter of 2015, with over 600patients planned to be enrolled in the trial. In this trial, we are randomizing patients to two doses of ITI-007 (60 mg or 20 mg), risperidone (active control) orplacebo over a 6-week treatment duration, and the primary outcome measure is change from baseline to Day 42 on the PANSS total score. We expect patientenrollment will be completed in the second quarter of 2016. Subject to timely enrollment, we anticipate top-line results from the second Phase 3 clinical trial willbe available in mid-2016.In addition to our two Phase 3 clinical trials, we will need to complete other clinical and non-clinical trials and manufacturing and pre-commercializationactivities necessary to support the submission of a planned New Drug Application, or NDA, for ITI-007 in schizophrenia, which we currently expect could occur inthe first half of 2017.ITI-007 for the Treatment of Depressive Episodes Associated with Bipolar Disorder (Bipolar Depression)Our bipolar depression program consists of two Phase 3 multi-center, randomized, double-blind, placebo-controlled clinical trials: one to evaluate ITI-007 asa monotherapy and the other to evaluate ITI-007 as an adjunctive therapy with lithium or valproate. In each trial, approximately 550 patients with a clinicaldiagnosis of Bipolar I or Bipolar II disorder and who are experiencing a current major depressive episode will be randomized to receive one of three treatments: 60mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio orally once daily for 6 weeks. In the ITI-007-401 trial, patients will receive ITI-007 or placebo as amonotherapy. In the ITI-007-402 trial, patients will receive ITI-007 or placebo adjunctive to their existing mood stabilizer lithium or valproate. We initiated ourbipolar depression program in the third quarter of 2015.The primary endpoint for both clinical trials is change from baseline at Day 42 on the Montgomery-Åsberg Depression Rating Scale, or MADRS, total scoreversus placebo. The MADRS is a well-validated 10-item checklist that measures the ability of a drug to reduce overall severity of depressive symptoms. Individualitems are rated by an expert clinician on a scale of 0 to 6 in which a score of 6 represents the most depressed evaluation for each item assessed. The total scoreranges from 0 to 60. Secondary endpoints include measures of social function and quality of life that may illustrate the differentiated clinical profile of ITI-007.Safety and tolerability are also assessed in both clinical trials. 5Table of ContentsOther Indications for ITI-007In the fourth quarter of 2014, we announced the top-line data from ITI-007-200, a Phase 1/2 clinical trial designed to evaluate the safety, tolerability andpharmacokinetics of low doses of ITI-007 in healthy geriatric subjects and in patients with dementia, including Alzheimer’s disease. The completion of this studymarks an important milestone in our strategy to develop low doses of ITI-007 for the treatment of behavioral disturbances associated with dementia and relateddisorders. The ITI-007-200 trial results to date indicate that ITI-007 is safe and well-tolerated across a range of low doses, has linear- and dose-relatedpharmacokinetics and improves cognition in the elderly. The most frequent adverse event was mild sedation at the higher doses. We believe these results furtherposition ITI-007 as a development candidate for the treatment of behavioral disturbances in patients with dementia and other neuropsychiatric and neurologicalconditions. We plan to initiate late phase clinical programs evaluating ITI-007 in patients with behavioral disturbances associated with dementia and relateddisorders, including Alzheimer’s disease, in the first half of 2016.We are also pursuing clinical development of ITI-007 for the treatment of additional CNS diseases and disorders. At the lowest doses, ITI-007 has beendemonstrated to act primarily as a potent 5-HT2A serotonin receptor antagonist. As the dose is increased, additional benefits are derived from the engagement ofadditional drug targets, including modest dopamine receptor modulation and modest inhibition of serotonin transporters. We believe that combined interactions atthese receptors may provide additional benefits above and beyond selective 5-HT2A antagonism for treating agitation, aggression and sleep disturbances indiseases that include dementia, Alzheimer’s disease, Huntington’s disease and autism spectrum disorders, while avoiding many of the side effects associated withmore robust dopamine receptor antagonism. As the dose of ITI-007 is further increased, leading to moderate dopamine receptor modulation, inhibition of serotonintransporters, and indirect glutamate modulation, these actions complement the complete blockade of 5-HT2A serotonin receptors. At a dose of 60 mg, ITI-007 hasbeen shown effective in treating the symptoms associated with schizophrenia, and we believe this higher dose range will be useful for the treatment of bipolardisorder, depressive disorders and other neuropsychiatric diseases.Given the potential utility for ITI-007 and follow-on compounds to treat these additional indications, we may investigate, either on our own or with a partner,agitation, aggression and sleep disturbances in additional diseases that include autism spectrum disorders; depressive disorder; intermittent explosive disorder; non-motor symptoms and motor complications associated with Parkinson’s disease; and post-traumatic stress disorder. We hold exclusive, worldwidecommercialization rights to ITI-007 and a family of compounds from Bristol-Myers Squibb Company pursuant to an exclusive license.Other Product CandidatesWe have a second major program called ITI-002 that has yielded a portfolio of compounds that selectively inhibits the enzyme phosphodiesterase type 1, orPDE1. We believe PDE1 helps regulate brain activity related to cognition, memory processes and movement/coordination. On February 25, 2011, we (through ourwholly owned operating subsidiary, ITI) and Takeda Pharmaceutical Company Limited, or Takeda, entered into a license and collaboration agreement, or theTakeda License Agreement, under which we agreed to collaborate to research, develop and commercialize our proprietary compound ITI-214 and other selectedcompounds that selectively inhibit PDE1 for use in the prevention and treatment of human diseases. On October 31, 2014, we entered into an agreement withTakeda terminating the Takeda License Agreement, or the Termination Agreement, pursuant to which all rights granted under the Takeda License Agreement werereturned to us. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug application, or IND, for ITI-214 to us. ITI-214 is the firstcompound in its class to successfully advance into Phase 1 clinical trials. We intend to pursue the development of our PDE program, including ITI-214 for thetreatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease, cognition inschizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also being advanced for the treatment of various indications. 6Table of ContentsOur pipeline also includes pre-clinical programs that are focused on advancing drugs for the treatment of schizophrenia, Parkinson’s disease, Alzheimer’sdisease and other neuropsychiatric and neurodegenerative disorders. We are also investigating the development of treatments for disease modification ofneurodegenerative disorders and non-CNS diseases.We have assembled a management team with significant industry experience to lead the discovery and development of our product candidates. Wecomplement our management team with a group of scientific and clinical advisors that includes recognized experts in the fields of schizophrenia and other CNSdisorders, including Nobel laureate, Dr. Paul Greengard, one of our co-founders.We were originally incorporated in the State of Delaware in August 2012 under the name “Oneida Resources Corp.” Prior to a reverse merger that occurredon August 29, 2013, or the Merger, Oneida Resources Corp. was a “shell” company registered under the Securities Exchange Act of 1934, or the Exchange Act,with no specific business plan or purpose until it began operating the business of ITI, Inc., or ITI, through the Merger transaction on August 29, 2013. ITI wasincorporated in Delaware in May 2001 to focus primarily on the development of novel drugs for the treatment of neuropsychiatric and neurologic diseases andother disorders of the CNS. Effective upon the Merger, a wholly-owned subsidiary of the Company merged with and into ITI, and ITI continues as the operatingsubsidiary of the Company. As used herein, the words the “Company,” “we,” “us,” and “our” refer to the current Delaware corporation operating the business ofITI as a wholly-owned subsidiary, which business continues as the business of the Company.Our corporate headquarters and laboratory are located at 430 East 29th Street, New York, New York 10016, and our telephone number is (646) 440-9333.We also have an office in Towson, Maryland. We maintain a website at www.intracellulartherapies.com, to which we regularly post copies of our press releases aswell as additional information about us. Our filings with the SEC will be available free of charge through the Investor Relations section of our website as soon asreasonably practicable after being electronically filed with or furnished to the SEC. Information contained in our website does not constitute a part of this report orour other filings with the SEC.Our StrategyOur goal is to discover and develop novel small molecule therapeutics for the treatment of CNS diseases in order to improve the lives of people sufferingfrom such illnesses. Using our key understanding of intracellular signaling, we seek to accomplish our goal, using our in-house expert drug discovery and clinicaldevelopment teams, in two ways: • we seek to have the capability to develop first-in-class medications with novel mechanisms that have the potential to treat CNS diseases for whichthere are no previously marketed drugs; and • we seek to develop drugs that either can differentiate themselves in competitive markets by addressing aspects of CNS disease which are not treated bycurrently marketed drugs or can be effective with fewer side effects.The key elements of our strategy are to: • complete the development of ITI-007 for its lead indication, treatment of schizophrenia, and for additional neuropsychiatric indications, such asbipolar disorder and residual symptoms in schizophrenia; • expand the commercial potential of ITI-007 by investigating its usefulness in neurological areas, such as behavioral disturbances in dementia,including Alzheimer’s disease and autism spectrum disorder, and in additional neuropsychiatric indications, such as sleep disorders associated withneuropsychiatric and neurological disorders and major depressive disorder; 7Table of Contents • continue to develop PDE inhibitor compounds, such as ITI-214, for the treatment of CNS and other disorders; and • advance earlier stage product candidates in our pipeline.Our Drug Discovery Platform and CapabilitiesBased on the pioneering efforts of our co-founder and Nobel laureate, Dr. Paul Greengard, we have developed a detailed understanding of intracellularsignaling pathways and intracellular targets. We have used that knowledge to develop several state of the art technology platforms, including one called CNSProfileTM . This technology monitors the phosphoprotein changes elicited by major psychotropic drug classes and subclasses, and generates a unique molecular signaturefor drug compounds. By monitoring how the levels of these phosphoproteins change in vivo , we identify intracellular signaling pathways through which severalmajor drug classes operate. Along with what we believe to be state of the art drug discovery efforts, we have used, and may continue to use, this information as atool to validate our selection of preclinical candidate molecules.During the years ended December 31, 2015 and 2014, we incurred $87.7 million and $21.2 million in research and development expenses, respectively.Given the nature of our research and development and business activities, we do not expect that compliance with federal, state and local environmental lawswill result in material costs or have a significant negative effect on our operations.Disease and Market OverviewOur programs for small molecule therapeutics are designed to address various CNS diseases that we believe are underserved or unmet by currently availabletherapies and that represent large potential commercial market opportunities for us. Background information on the CNS diseases and related commercial marketsthat may be addressed by our programs is set forth below.SchizophreniaSchizophrenia is a disabling and chronic mental illness that is characterized by multiple symptoms during an acute phase of the disorder that can include so-called “positive” symptoms, such as hearing voices, grandiose beliefs and suspiciousness or paranoia. These symptoms can be accompanied by additional, harder totreat symptoms, such as social withdrawal, blunted emotional response and speech deficits, collectively referred to as “negative” symptoms, difficultyconcentrating and disorganized thoughts, or cognitive impairment, depression and insomnia. Such residual symptoms often persist even after the acute positivesymptoms subside, and contribute substantially to the social and employment disability associated with schizophrenia. Current antipsychotic medications providesome relief for the symptoms associated with the acute phase of the disorder, but they do not effectively treat the residual phase symptoms associated with chronicschizophrenia. Currently available medications used to treat acute schizophrenia are limited in their use due to side effects that can include movement disorders,weight gain, metabolic disturbances, and cardiovascular disorders. Indeed, the side effects associated with current antipsychotic medications often make some ofthe residual phase symptoms, such as negative symptoms and social function, worse. There is an unmet medical need for new therapies that have improved sideeffect and efficacy profiles.According to the National Institute of Mental Health, over 1% of the world’s population suffers from schizophrenia, and more than 2.5 million Americanssuffer from the illness in any given year. Worldwide sales of antipsychotic drugs exceeded $14 billion in 2014. These drugs have been increasingly used byphysicians to address a range of disorders in addition to schizophrenia, including bipolar disorder and a variety of psychoses and related conditions in elderlypatients. Despite their commercial success, current antipsychotic drugs have substantial limitations, including inadequate efficacy and severe side effects. 8Table of ContentsThe first-generation, or typical, antipsychotics that were introduced in the late-1950s block dopamine receptors. While typical antipsychotics are effectiveagainst positive symptoms of schizophrenia in many patients, these drugs often induce disabling motor disturbances, and they fail to address or worsen most of thenegative symptoms and cognitive disturbances associated with schizophrenia.Most schizophrenia patients in the United States are treated today with second-generation, or atypical, antipsychotics, which induce fewer motordisturbances than typical antipsychotics, but still fail to address most of the negative symptoms of schizophrenia and other symptoms associated with socialfunction impairment. Many patients with schizophrenia have deficits in social function. Social function is the ability to recognize, understand, process and useexternal cues to solve problems, maintain work performance, and conduct interpersonal relationships. Deficits in social function often remain after positivesymptoms, such as hallucinations and delusions, have resolved in these patients. In addition, currently prescribed treatments do not effectively address or mayexacerbate cognitive disturbances associated with schizophrenia. It is believed that the efficacy of atypical antipsychotics is due to their interactions with dopamineand 5-HT2A receptors. The side effects induced by the atypical agents may include weight gain, non-insulin dependent (type II) diabetes, cardiovascular sideeffects, sleep disturbances, and motor disturbances. We believe that these side effects generally arise either from non-essential receptor interactions or fromexcessive dopamine blockade.The limitations of currently available antipsychotics result in poor patient compliance. A landmark study funded by the National Institute of Mental Health,the Clinical Antipsychotic Trials of Intervention Effectiveness, also referred to as CATIE, which was published in The New England Journal of Medicine inSeptember 2005, found that 74% of patients taking typical or atypical antipsychotics discontinued treatment within 18 months because of side effects or lack ofefficacy. We believe there is a large underserved medical need for new therapies that have improved side effect and efficacy profiles.Bipolar DisorderBipolar disorder, sometimes referred to as manic-depressive illness, is characterized by extreme shifts in mood. Individuals with bipolar disorder mayexperience intense feelings of over-excitement, irritability, and impulsivity with grandiose beliefs and racing thoughts, referred to as a manic episode. Symptoms ofdepression may include feeling tired, hopeless and sad, with difficulty concentrating and thoughts of suicide. Some people experience both types of symptoms inthe same “mixed” episode. Severe symptoms of bipolar disorder can be associated with hallucinations or delusions, otherwise referred to as psychosis.Bipolar disorder affects approximately 5.7 million adults in the United States in any given year, or about 2.6 percent of the adult U.S. population. In 2012,therapeutics used to treat bipolar disorder had global sales of approximately $6 billion.Bipolar disorder is often treated with antipsychotic medications alone or in combination with mood stabilizers. The side effects and safety risks associatedwith antipsychotic drugs in patients with bipolar disorder are similar to those experienced by patients with schizophrenia. Moreover, a large national researchprogram conducted from 1998 to 2005 called the Systematic Treatment Enhancement Program for Bipolar Disorder, or STEP-BD, followed 4,360 patients withbipolar disorder long term and showed that about half of patients who were treated for bipolar disorder still experienced lingering and recurrent symptoms,indicating a clear need for improved treatments.Behavioral Disturbances in Dementia, Including Alzheimer’s DiseaseIt has been estimated that 44.4 million people worldwide were living with dementia in 2013, including over 5.2 million patients with Alzheimer’s disease inthe United States. This number is expected to increase to 75.6 million by 2030 and to increase to 135.5 million by 2050. While the diagnostic criteria forAlzheimer’s disease and other dementias mostly focus on the related cognitive deficits, it is often the behavioral and psychiatric symptoms that are mosttroublesome for caregivers and lead to poor quality of life for patients. 9Table of ContentsSeveral behavioral symptoms are quite prevalent in patients with dementia, including patients with Alzheimer’s disease. In view of the potential multiple effects ofITI-007 on aggression, agitation, sleep disorders and depression, and its safety profile to date, we believe that ITI-007 may provide a novel therapy for treating thebehavioral disturbances accompanying dementia, including Alzheimer’s disease.The FDA has not approved any drug to treat the behavioral symptoms of dementia, including Alzheimer’s disease. As symptoms progress and become moresevere, physicians often resort to off-label use of antipsychotic medications in these patients. Current antipsychotic drugs are associated with a number of sideeffects, which can be problematic for elderly patients with dementia. In addition, antipsychotic drugs may exacerbate the cognitive disturbances associated withdementia. We believe there is a large unmet medical need for a safe and effective therapy to treat the behavioral symptoms in patients with dementia, includingAlzheimer’s disease.Alzheimer’s DiseaseAlzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills, and eventually even the ability to carry outsimple tasks. Its symptoms include cognitive dysfunction, memory abnormalities, progressive impairment in activities of daily living, and a host of behavioral andneuropsychiatric symptoms. Alzheimer’s disease primarily affects older people and, in most cases, symptoms first appear after age 60. Alzheimer’s disease getsworse over time and is fatal.The market for Alzheimer’s disease therapeutics is categorized into two segments: acetylcholinesterase inhibitors and NMDA receptor antagonists, whichinclude Aricept ® , Namenda ® , Exelon ® and Ebixa ® . These two segments had total sales of $4.9 billion in 2013.According to the Alzheimer’s Association, 5.2 million people in the United States are living with Alzheimer’s disease, and it is currently the fifth leadingcause of death for people age 65 and older. It has been estimated that 44.4 million people worldwide were living with dementia in 2013. This number is expected toincrease to 75.6 million by 2030 and to increase to 135.5 million by 2050. While the diagnostic criteria for Alzheimer’s disease mostly focus on the relatedcognitive deficits, it is often the behavioral and psychiatric symptoms that are most troublesome for caregivers and lead to poor quality of life for patients. Thesesymptoms include agitation, aggressive behaviors, depression, sleep disorders, and psychosis. Studies have suggested that approximately 60% of patients withAlzheimer’s disease experience agitation/aggression, up to 87% of patients experience depression, approximately 60% of patients experience sleep disturbances,particularly as an increased likelihood of day-night reversal, and approximately 20% to 51% of Alzheimer’s disease patients may develop psychosis at some pointin the disease process, commonly consisting of hallucinations and delusions. The diagnosis of Alzheimer’s disease psychosis is associated with more rapidcognitive and functional decline and institutionalization. Sleep disturbances increase the likelihood of day-night reversion, increased agitation and increasedcaregiver stress that strongly influences decisions for nursing home placement.The FDA has not approved any drug to treat the behavioral symptoms of Alzheimer’s disease. As symptoms progress and become more severe, physiciansoften resort to off-label use of antipsychotic medications in these patients. Current antipsychotic drugs are associated with a number of side effects, which can beproblematic for elderly patients with Alzheimer’s disease. In addition, antipsychotic drugs may exacerbate the cognitive disturbances associated with Alzheimer’sdisease. Current antipsychotic drugs also have a boxed warning for use in elderly patients with dementia-related psychosis due to increased mortality andmorbidity. There is a large unmet medical need for a safe and effective therapy to treat the behavioral symptoms in patients with Alzheimer’s disease.Parkinson’s DiseaseParkinson’s disease is a chronic and progressive neurodegenerative disorder that involves malfunction and death of neurons in a region of the brain thatcontrols movement. This neurodegeneration creates a shortage of an important brain signaling chemical, or neurotransmitter, known as dopamine, therebyrendering patients unable 10Table of Contentsto direct or control their movements in a normal manner. Parkinson’s disease is characterized by well-known motor symptoms, including tremors, limb stiffness,slowness of movements, and difficulties with posture and balance, as well as by non-motor symptoms, which include sleep disturbances, mood disorders, cognitiveimpairment and psychosis. Parkinson’s disease progresses slowly in most people and the severity of symptoms tends to worsen over time.Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s disease. According to the National Parkinson Foundation,about 1 million people in the United States and from approximately 4 to 6 million people worldwide suffer from this disease. Parkinson’s disease is more commonin people over 60 years of age, and the prevalence of this disease is expected to increase significantly as the average age of the population increases. Parkinson’sdisease patients are commonly treated with dopamine replacement therapies, such as levodopa, commonly referred to as L-DOPA, which is metabolized todopamine, and dopamine agonists, which are molecules that mimic the action of dopamine. Sales of therapeutics such as L-DOPA and dopamine agonists used totreat the motor symptoms of the disease reached $2.3 billion in 2013.Non-motor symptoms can be particularly distressing and even more troublesome to patients with Parkinson’s disease than the primary motor disturbances.Non-motor symptoms substantially contribute to the burden of Parkinson’s disease and deeply affect the quality of life of patients and their caregivers. Non-motorsymptoms of Parkinson’s disease are associated with increased caregiver stress and burden, nursing home placement, and increased morbidity and mortality.Treatment of non-motor symptoms associated with Parkinson’s disease poses a challenge to physicians. Current dopamine replacement drugs used to treatthe motor symptoms of Parkinson’s disease do not help, and sometimes worsen, the non-motor symptoms. No drugs are currently approved by the FDA for treatingthe broad non-motor symptoms associated with Parkinson’s disease, and this remains a large unmet medical need.DepressionMajor depressive disorder, or MDD, is a brain disorder that can be associated with symptoms of sadness, hopelessness, helplessness, feelings of guilt,irritability, loss of interest in formerly pleasurable activities, cognitive impairment, disturbed sleep patterns, and suicide ideation or behavior. Different people mayexperience different symptoms, but everyone with major depression experiences symptoms that are severe enough to interfere with everyday functioning, such asthe ability to concentrate at work or school, social interactions, eating and sleeping. Sometimes the depressive episode can be so severe it is accompanied bypsychosis (hallucinations and delusions). According to the National Institute of Mental Health, approximately 3% of teenagers and approximately 7% of adultsexperience MDD each year. Worldwide sales of antidepressant drugs reached $9.3 billion in 2013. The antidepressant market is primarily composed of selectiveserotonin reuptake inhibitors such as Lexapro ® (marketed by Forest Laboratories and Lundbeck) and selective norepinephrine reuptake inhibitors, or SNRIs, suchas Cymbalta ® (marketed by Eli Lilly). Antipsychotics such as Seroquel ® (marketed by Astrazeneca) and Abilify ® (marketed jointly by Bristol-Myers Squibb andOtsuka Pharmaceutical) are also used as adjunctive treatments with antidepressant treatment. The National Institute of Mental Health-funded Sequenced TreatmentAlternatives to Relieve Depression, or STAR*D, study showed that only one-third of treated patients experience complete remission of depressive symptoms.Nearly two-thirds of patients were considered treatment-resistant. 11Table of ContentsOur Clinical ProgramsOur pipeline includes two product candidates in clinical development and two product candidates in advanced pre-clinical testing. We believe that ourproduct candidates offer innovative therapeutic approaches and may provide significant advantages relative to current therapies. The following table summarizesour product candidates and programs:OUR THERAPEUTIC PIPELINE ITI-007 ProgramOur lead product candidate, ITI-007, possesses mechanisms of action that we believe may represent an effective treatment across multiple therapeuticindications. ITI-007 is in Phase 3 clinical trials for the treatment of schizophrenia. In our pre-clinical and clinical trials to date, we have demonstrated that ITI-007combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, or DPPM, glutamatergic modulation and serotoninreuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia. At dopamine D2 receptors, ITI-007 has been demonstrated tohave dual properties and to act as both a pre-synaptic partial agonist and a post-synaptic antagonist. ITI-007 has also been demonstrated to have affinity fordopamine D1 receptors and indirectly stimulate phosphorylation of glutamatergic NMDA NR2B, or GluN2B, receptors in a mesolimbic specific manner. Webelieve that this regional selectivity in brain areas thought to mediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, anddopaminergic interactions, may result in antipsychotic efficacy for positive, negative, affective and cognitive symptoms associated with schizophrenia. Theserotonin reuptake inhibition could allow for antidepressant activity for the treatment of schizoaffective disorder, other disorders with co-morbid depression, and/oras a stand-alone treatment for major depressive disorder. We believe ITI-007 may also be useful for the treatment of bipolar disorder and other psychiatric andneurodegenerative disorders, particularly behavioral disturbances associated with dementia, autism and other CNS diseases.We believe these features of ITI-007 may be able to improve the quality of life of patients with schizophrenia and enhance social function to allow them tointegrate more fully into their families and their 12Table of Contentsworkplaces. In addition, ITI-007 may be shown to treat disorders at either low-doses ( e.g., sleep, aggression and agitation) or high-doses ( e.g. , acute exacerbatedand residual schizophrenia, bipolar disorders, and mood disorders).Phase 1 studies to support multiple clinical indicationsWe conducted a series of Phase 1 safety studies of ITI-007 in Europe and the United States during the period from 2007 to 2011. All of the studies conductedto date in the United States have been conducted under an Investigational New Drug application, or IND, filed in 2007 by ITI. Data from these studies are beingused to support the clinical development of ITI-007 in multiple indications, including schizophrenia, sleep disorders in neuropsychiatric and neurodegenerativedisease, major depressive disorders, bipolar disorders, behavioral disturbances in dementia and Alzheimer’s disease, autism, posttraumatic stress disorder, or PTSD,and intermittent explosive disorder, or IED. We have completed the following three Phase 1 trials in healthy volunteers: • A Phase 1, double-blind placebo controlled, single ascending dose study in 40 healthy volunteers in Europe in 2007. ITI-007 was generally welltolerated at all doses. Most adverse events, or AEs, were mild to moderate and all treatment related AEs resolved. The most frequent AE washeadache. • A Phase 1, placebo controlled multiple ascending dose study in 25 healthy volunteers in Europe from 2007 to 2008. ITI-007 was generally welltolerated at all doses. Most AEs were mild to moderate and all treatment related AEs resolved. • A Phase 1, open-label positron emission tomography, or PET, study to demonstrate receptor occupancy, safety, tolerability and pharmacokinetics aftersingle oral dose administration of ITI-007 in 16 healthy male volunteers. This study was conducted in the United States from 2007 to 2009. ITI-007was well tolerated, all AEs were of mild or moderate intensity and all treatment related AEs resolved. Dose related increases in receptor occupancy atdopamine D2 receptors in the striatum were demonstrated after ITI-007 administration. Brain occupancy at 5-HT2A and serotonin reuptaketransporters also was demonstrated after single doses of ITI-007.We continued Phase 1 development of ITI-007 in patients with schizophrenia in order to advance ITI-007 in this target therapeutic indication. Specifically,we conducted the following additional studies: • A Phase 1b/2, placebo controlled multiple ascending dose study in 45 patients with stable schizophrenia in the United States during 2009 to 2010. ITI-007 was generally well tolerated at all doses. All AEs were mild to moderate and all treatment related AEs resolved. The overall percentage of patientsreporting treatment related AEs was similar for those treated with ITI-007 (83.3% to 100%, across dose groups) and placebo (72.7%). The majority ofthe treatment related AEs that occurred at the commencement of the study decreased in terms of frequency and/or severity with repeatedadministration. We observed signs consistent with clinical efficacy in stable patients with schizophrenia in this study. • A Phase 1, randomized study to determine the tolerability, safety and pharmacokinetics of ITI-007 using different dosing regimens in 11 patients withschizophrenia. This study was conducted in the United States in 2011. In this study, we showed that administration of ITI-007 in a capsule dosageform taken with food reduced the incidence of treatment related AEs and all treatment related AEs resolved. The most commonly reported treatmentrelated AE in this study was somnolence, commonly known as drowsiness.ITI-007 for the treatment of exacerbated and residual schizophreniaIn multiple clinical trials of ITI-007 in patients with schizophrenia, the drug candidate has demonstrated clinical signals consistent with reductions inpsychosis, depression and insomnia. Reductions in psychosis are consistent with the potential to treat acute schizophrenia, whereas reductions in depression andinsomnia are 13Table of Contentsconsistent with the potential to treat residual phase schizophrenia. ITI-007 has been shown to be safe and well-tolerated across a wide range of doses in thesestudies. Further, at doses that have demonstrated clinical activity, ITI-007 has caused fewer adverse effects than those typically associated with antipsychotic drugtreatment, such as impaired motor function. These adverse side effects can be a major cause of patient noncompliance with current antipsychotic therapies and canlead to poorer social function.Phase 2 Clinical Trial (ITI-007-005)ITI-007 exhibited antipsychotic efficacy in ITI-007-005, a randomized, double-blind, placebo and active controlled Phase 2 clinical trial in patients with anacutely exacerbated episode of schizophrenia. In December 2013, we announced the clinical results from this Phase 2 trial. In this Phase 2 trial, 335 patients wererandomized to receive one of four treatments: 60 mg of ITI-007, 120 mg of ITI-007, 4 mg of risperidone (active control) or placebo in a 1:1:1:1 ratio. Patientsreceived study treatment orally once daily in the morning for 28 days. Of those randomized, 311 patients were included in the intent-to-treat primary analysis.Subject participation lasted approximately 7 to 8 weeks, including a one week screening period, a four week treatment period followed by stabilization on standardof care, and a safety follow up visit approximately two weeks after stabilization. The primary endpoint for this clinical trial was change from baseline to Day 28 onthe PANSS total score. The PANSS is a well-validated 30-item rating scale that measures the ability of a drug to reduce schizophrenia symptom severity. ThePANSS measures positive symptoms, such as delusions, suspiciousness, and hallucinations; negative symptoms, such as blunted affect, social and emotionalwithdrawal, and stereotyped thinking; and general psychopathology, such as anxiety, tension, depression, and active social avoidance.Secondary endpoints in this trial included weekly assessments of the PANSS total score as well as its subscales (Positive Symptom Subscale, NegativeSymptom Subscale, and General Psychopathology Subscale) and the Negative Symptom Factor (based on a subset of PANSS questions), individual item responseon the PANSS, and the Calgary Depression Scale for Schizophrenia. Safety and tolerability were also assessed.In December 2013, we announced that topline results from the ITI-007-005 study indicated that ITI-007 met the trial’s pre-specified primary endpoint,improving symptoms associated with schizophrenia as measured by a statistically significant and clinically meaningful decrease in the PANSS total score. The trialalso met key secondary outcome measures related to efficacy on PANSS subscales and safety.Many patients with schizophrenia have deficits in social function. Social function is the ability to recognize, understand, process and use external cues tosolve problems, maintain work performance and conduct interpersonal relationships. Deficits in social function often remain after positive symptoms, such ashallucinations and delusions, have resolved in these patients. In the Phase 2 trial, ITI-007 exhibited a differentiating response profile across a broad range ofsymptoms that we believe is consistent with improvements in these social functioning deficits. The study also showed that ITI-007 was well-tolerated at the testeddoses. ITI-007 demonstrated a favorable safety profile in the study without characteristic antipsychotic drug side effects or any serious adverse events.ITI-007 at a dose of 60 mg demonstrated a statistically significant improvement in psychosis (p = 0.017) on the trial’s pre-specified primary endpoint, whichwas change from baseline on the PANSS total score, compared to placebo. The primary statistical analysis was pre-specified and used a Mixed-Effect ModelRepeated Measure method for handling missing data in the intent-to-treat, or ITT, study population and a Bonferroni procedure to correct for multiple two-sidedcomparisons (each dose of ITI-007 compared to placebo). The trial’s pre-specified sensitivity analysis on the primary endpoint used the analysis of covariance, orANCOVA, model and last observation carried forward, or LOCF, method for handling missing data for the ITT population and confirmed the positive outcomewith statistically significant improvements compared to placebo in patients receiving the 60 mg dose of ITI-007 (p = 0.011). ITI-007 at a dose of 60 mg alsosignificantly improved the positive symptom subscale (p < 0.05) and the general psychopathology subscale (p < 0.05) on the PANSS after 28 days of treatmentusing the ANCOVA-LOCF on the ITT population. 14Table of ContentsThe improvement in the PANSS total score in the 120 mg dose group did not reach statistical significance. We believe that it is possible that sedation, themost frequent side effect in the 120 mg dose group, interfered with the ability to detect an efficacy signal at this dose administered once daily in the morning.Approximately 32.5% of subjects randomized to 120 mg of ITI-007 experienced sedation/somnolence, compared to 21% of subjects randomized to risperidone,17% of subjects randomized to 60 mg of ITI-007, and 13% randomized to placebo. We believe that nighttime administration may be more appropriate for testingthe effectiveness of the 120 mg dose of ITI-007 in this patient population. In the trial, the 60 mg dose of ITI-007 was effective when administered once daily in themorning.Consistent with preliminary indications from the interim analysis and with the drug candidate’s pharmacological profile, ITI-007 at a dose of 60 mgsignificantly improved certain items on the negative symptom and general psychopathology subscales consistent with improved social function. The study wasstatistically powered only on the primary endpoint. ITI-007 did significantly improve many secondary endpoints, although the study was not designed forsignificance on secondary endpoints and was not powered to detect statistical differences in subgroup analyses.A high percentage (74%) of randomized subjects completed trial participation. Only 19% of subjects discontinued from study treatment during the 28 daystudy treatment period, and an additional 7% of subjects completed study treatment but were lost to follow up.In the Phase 2 trial, ITI-007 was well-tolerated. The most frequent AE was sedation, as described above. There were no serious adverse events related to ITI-007. There were no clinically meaningful changes in safety measures with ITI-007. Notably, ITI-007 demonstrated a favorable metabolic profile with no increaseof blood levels of glucose, insulin, cholesterol or triglycerides over a four week treatment period. Moreover, in contrast to risperidone, 60 mg of ITI-007 waseffective with no difference from placebo on weight change parameters, prolactin levels, extrapyramidal symptoms (EPS) or akathisia. ITI-007 was not associatedwith EPS as measured by the Simpson-Angus Scale, Barnes Akathisia Rating Scale, or Abnormal Involuntary Movement Scale. There was no increase in suicidalideation or behavior with ITI-007.Phase 3 Clinical Trials and Regulatory PlansWe are proceeding with Phase 3 development of ITI-007 for the treatment of schizophrenia. We are conducting two randomized, double-blind, placebo-controlled Phase 3 clinical trials of ITI-007 in patients with acutely exacerbated schizophrenia. In September 2015, we announced top-line clinical results from ourfirst Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia. This randomized, double-blind, placebo-controlled Phase 3 clinical trial wasconducted at 12 sites in the United States with 450 patients randomized (1:1:1) to receive either 60 mg of ITI-007, 40 mg of ITI-007 or placebo once daily in themorning for 28 days. The pre-specified primary efficacy measure was change from baseline versus placebo at study endpoint (4 weeks) on the centrally ratedPositive and Negative Syndrome Scale, or PANSS, total score. In this trial, the once-daily dose of 60 mg of ITI-007 met the primary endpoint and demonstratedantipsychotic efficacy with statistically significant superiority over placebo at week 4 (study endpoint) with additional improvements observed in social function.Moreover, the 60 mg dose of ITI-007 showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the entirestudy. ITI-007 showed a dose-related improvement in symptoms of schizophrenia with the 40 mg dose approximating the trajectory of improvement seen with the60 mg dose, but the effect with 40 mg did not reach statistical significance on the primary endpoint. In addition, the 60 mg dose of ITI-007 met the key secondaryendpoint of statistically significant improvement on the Clinical Global Impression Scale for Severity of Illness, or CGI-S. The 40 mg dose of ITI-007 alsodemonstrated a statistically significant improvement versus placebo on the CGI-S, though not formally tested against placebo since it did not separate on theprimary endpoint. Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile as evidenced by motoric, metabolic, and cardiovascularcharacteristics similar to placebo, and no clinically significant changes in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin, or lipids.We are also conducting a second Phase 3 clinical trial in schizophrenia that we initiated in the second quarter of 2015, with over 600 patients 15Table of Contentsplanned to be enrolled in the trial. In this trial, we are randomizing patients to two doses of ITI-007 (60 mg or 20 mg), risperidone (active control) or placebo over a6-week treatment duration, and the primary outcome measure is change from baseline to Day 42 on the PANSS total score. We expect patient enrollment will becompleted in the second quarter of 2016. Subject to timely enrollment, we anticipate top-line results from the second Phase 3 clinical trial will be available in mid-2016.In addition to our Phase 3 clinical trials, we will need to complete other clinical and non-clinical trials and manufacturing and pre-commercializationactivities necessary to support the submission of a planned NDA for ITI-007 in schizophrenia, which we currently expect could occur in the first half of 2017.Additional meetings with the FDA may be requested, as needed, to discuss in greater detail our plans for schizophrenia, and other elements of our regulatorystrategy, including additional therapeutic indications, as the program progresses. Our clinical plans may change based on any discussions with the FDA, the relativesuccess and cost of our research, preclinical and clinical development programs, whether we are able to enter into future collaborations, and any unforeseen delaysor cash needs. If the FDA does not agree with our clinical development plans for ITI-007, our development of ITI-007 may be delayed and the costs of ourdevelopment of ITI-007 could increase, which would have a material adverse effect on our business, financial condition and results of operations.We are also developing long acting injectable formulations of ITI-007 for the treatment of schizophrenia. This is a pre-clinical stage development program.PET study of ITI-007 in patients with stable schizophreniaOn September 16, 2015, we announced top-line data from an open-label positron emission tomography, or PET, study of ITI-007 examining brain occupancyof striatal D2 receptors. This study was conducted in patients diagnosed with schizophrenia who were otherwise healthy and stable with respect to their psychosis.After washout from their previous antipsychotic medication for at least two weeks, PET was used to determine target occupancy in brain regions at baseline (drug-free) and again after two weeks of once daily ITI-007 oral administration. In this trial, the 60 mg dose of ITI-007 was associated with a mean of approximately 40%striatal dopamine D 2 receptor occupancy. As predicted by preclinical and earlier clinical data, ITI-007 demonstrated antipsychotic effect at relatively low striatal D2 receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. Unlike any existing schizophrenia treatment, this dopaminereceptor phosphoprotein modulator, or DPPM, acts as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors. We believe this mechanism likelycontributes to the favorable safety profile of ITI-007, with reduced risk for hyperprolactinemia, akathisia, extrapyramidal symptoms, and other motoric side effects.ITI-007 for the treatment of depressive episodes associated with bipolar disorder (bipolar depression)The pharmacological profile of ITI-007 offers the potential to treat bipolar mania, depression, and mixed symptoms at doses similar to those targeted for thetreatment of schizophrenia. We believe that ITI-007 may be effective alone or in combination with mood stabilizers. Given that many patients with bipolar disorderalso experience disturbed sleep and cognitive impairment similar to that observed in schizophrenia, we believe that ITI-007 may treat a wide array of symptoms inpatients with bipolar disorder, including improvement of cognition and sleep.Our bipolar depression program consists of two Phase 3 multi-center, randomized, double-blind, placebo-controlled clinical trials: one to evaluate ITI-007 asa monotherapy and the other to evaluate ITI-007 as an adjunctive therapy with lithium or valproate. In each trial, approximately 550 patients with a clinicaldiagnosis of Bipolar I or Bipolar II disorder and who are experiencing a current major depressive episode will be randomized to receive one of three treatments: 60mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio orally once daily for 6 weeks. In the ITI-007-401 trial, patients will receive ITI-007 or placebo as amonotherapy. In the ITI-007-402 trial, patients will receive ITI-007 or placebo adjunctive to their existing mood stabilizer lithium or valproate. We initiated ourbipolar depression program in the third quarter of 2015.The primary endpoint for both clinical trials is change from baseline at Day 42 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total scoreversus placebo. The MADRS is a well-validated 10-item checklist that measures the ability of a drug to reduce overall severity of depressive symptoms. Individualitems are rated 16Table of Contentsby an expert clinician on a scale of 0 to 6 in which a score of 6 represents the most depressed evaluation for each item assessed. The total score ranges from 0 to 60.Secondary endpoints include measures of social function and quality of life that may illustrate the differentiated clinical profile of ITI-007. Safety and tolerabilityare also assessed in both clinical trials.ITI-007 for the treatment of behavioral disturbances associated with dementia, including Alzheimer’s diseaseBehavioral disturbances are common in dementia and Alzheimer’s disease. These disturbances are a major component of the burden to caregivers, and oftenlead to institutionalization. Although currently available treatments for patients with dementia mainly address cognitive disturbances, behavioral disturbances areconsiderably more problematic and likely more amenable to drug treatment. Several behavioral symptoms are quite prevalent in patients with dementia, includingpatients with Alzheimer’s disease. In the fourth quarter of 2014, we announced the top-line data from ITI-007-200, a Phase 1/2 clinical trial designed to evaluatethe safety, tolerability and pharmacokinetics of low doses of ITI-007 in healthy geriatric subjects and in patients with dementia, including Alzheimer’s disease. TheITI-007-200 clinical trial was conducted in two parts. Part 1 was a randomized, double-blind, placebo-controlled multiple ascending dose evaluation of ITI-007 inhealthy geriatric subjects. In each of three cohorts in Part 1, approximately 10 subjects were randomized to receive ITI-007 (N=8) or placebo (N=2) orally oncedaily in the morning for seven days. Doses of ITI-007 up to and including 30 mg were evaluated in three cohorts in Part 1. In Part 2, eight patients with dementiawere randomized to receive 9 mg ITI-007 (N=5) or placebo (N=3) orally once a day in the evening for seven days. The primary objectives of the study were toevaluate the safety, tolerability and pharmacokinetics of ITI-007 in the elderly and in the target dementia patient population. Secondary measures were included toexplore the effects of ITI-007 on cognition and agitation. The Hopkins Verbal Learning Test-R, or HVLT-R, was used to assess cognition in healthy geriatricsubjects and dementia patients. The results demonstrated impaired verbal learning and memory (recall and recognition memory) by dementia patients relative tohealthy geriatric subjects. Moreover, the data indicated that healthy geriatric subjects treated with ITI-007 for approximately one week experienced animprovement in verbal learning and memory relative to placebo-treated subjects. Dementia patients treated with ITI-007 showed enhanced recognition memory,making fewer false positive errors (i.e., responding ‘yes’ to non-target words) than patients treated with placebo. Other secondary endpoints in the ITI-007-200clinical trial included the assessment of agitation. However, none of the study participants experienced agitation at baseline or during the study, and therefore nosignals on this behavioral endpoint could be assessed. The completion of this study marks an important milestone in our strategy to develop low doses of ITI-007for the treatment of behavioral disturbances associated with dementia and related disorders. The ITI-007-200 trial results to date indicate that ITI-007 is safe andwell-tolerated across a range of low doses, has linear- and dose-related pharmacokinetics and improves cognition in the elderly. The most frequent adverse eventwas mild sedation at the higher doses. We believe these results further position ITI-007 as a development candidate for the treatment of behavioral disturbances inpatients with dementia and other neuropsychiatric and neurological conditions. We plan to initiate additional clinical programs evaluating ITI-007 in patients withbehavioral disturbances associated with dementia and related disorders, including Alzheimer’s disease, in the first half of 2016.ITI-007 for the treatment of sleep disturbances associated with neurologic and psychiatric disordersA Phase 2 double-blind, placebo controlled cross-over clinical trial conducted in 19 patients with primary insomnia with disturbed sleep maintenance at lowdoses of ITI-007 was completed in 2008 in Europe. The primary outcome measure was slow wave sleep as determined by polysomnography. ITI-007 demonstrateda dose-related statistically significant increase in slow wave sleep. Secondary measures were consistent with improvement of sleep maintenance in patients withprimary insomnia, indicated by decreased waking after sleep onset, increased total sleep time, and no increase in latency to sleep onset. At these low doses ITI-007did not induce sleep, but rather helped maintain sleep once sleep had been initiated. In addition, ITI-007 was not associated with next day cognitive impairment, or“hang-over” effects. We believe that ITI-007 may be particularly useful in the treatment of sleep disorders that accompany neuropsychiatric and neurologicdisorders, including schizophrenia, autism spectrum disorder, or ASD, Parkinson’s disease and dementia. Previous work 17Table of Contentshas suggested that selective 5-HT2A receptor antagonists increase deep, slow wave sleep in both humans and animals. We believe, however, that otherneuropharmacological mechanisms, in addition to 5-HT2A receptor antagonism, such as engaging some dopamine modulation, may be beneficial for the successfultreatment of sleep maintenance insomnia, or SMI, in humans. We believe that ITI-007 represents a new approach to the treatment of sleep maintenance insomniabecause of its unique pharmacology and neuropharmacological interactions beyond selective 5-HT2A receptor antagonism. We believe that ITI-007 offers apotentially new approach to the treatment of sleep maintenance disorders, particularly in those disorders that accompany neuropsychiatric and neurologic disorders.Many of these disorders are accompanied by profound sleep deficits, which impair daytime functioning including cognition, exacerbate disease symptoms andincrease the cost of care. We are presently exploring clinical designs to incorporate the examination of sleep disturbances in one or more of these indications. Thereis no assurance that any such design would be sufficient for an FDA approval for this indication.ITI-007 for the treatment of sleep and behavioral disturbances associated with autism spectrum disorderSleep problems are common in patients with ASD and are not adequately treated by currently available interventions. Approximately two thirds of childrenand adolescents with ASD experience sleep problems, higher than the rate of sleep problems in age-matched developmentally typical children. Moreover,individuals with ASD suffer from behavioral disturbances, including aggression, irritability, anxiety and depression. With its multiple pathway mechanism ofaction, we believe that ITI-007 could address the multi-faceted behavioral symptoms associated with ASD. 5-HT2A receptor antagonism is predicted to increaseslow wave sleep, improve sleep maintenance and reduce aggression. D2 receptor modulation is predicted to improve sleep maintenance and reduce irritability andaggression. Serotonin reuptake inhibition is predicted to reduce anxiety and depression. Accordingly, we believe that ITI-007 could improve sleep maintenance,reduce behavioral disturbances and enhance social interaction in patients with ASD. We believe that our completed Phase 1 studies support advancing ITI-007 intoPhase 2 trials in this patient population, and we are presently exploring the feasibility of such trials.ITI-007 for the treatment of depression and other mood disordersAs a potent 5-HT2A receptor antagonist and serotonin reuptake inhibitor, we believe that ITI-007 could improve symptoms of depression with fewer sideeffects than selective serotonin reuptake inhibitors, or SSRIs. Dopamine modulation by ITI-007 may reduce irritability and aggression that can accompany manymood disorders. As such, ITI-007 may be effective for the treatment of mood disorders including MDD, PTSD, and IED. We are presently exploring the feasibilityof clinical studies in these indications.ITI-002 (PDE1) ProgramWe have a second major program called ITI-002 that has yielded a portfolio of compounds that selectively inhibits the enzyme phosphodiesterase type 1, orPDE1. We believe PDE1 helps regulate brain activity related to cognition, memory processes and movement/coordination. In addition, PDE1 inhibitors may haveutility in treating non-CNS disorders. On February 25, 2011, we (through our wholly owned operating subsidiary, ITI) and Takeda Pharmaceutical CompanyLimited, or Takeda, entered into a license and collaboration agreement, or the Takeda License Agreement, under which we agreed to collaborate to research,develop and commercialize our proprietary compound ITI-214 and other selected compounds that selectively inhibit PDE1 for use in the prevention and treatmentof human diseases. Takeda conducted four Phase 1 studies. A single rising dose study was conducted in the U.S. in healthy male and female, Japanese and non-Japanese volunteers. In a second U.S. study, ITI-214 was administered once daily over 14 days to healthy volunteers and patients with stable schizophrenia. In athird study, conducted in Japan, ITI-214 was administered for seven days at multiple rising oral doses in both male and female healthy volunteers. A fourth studycompared the relative bioavailability of oral formulations of ITI-214 used in all previous studies to an immediate-release tablet, either with or without food inhealthy volunteers. In these studies, ITI-214 demonstrated a favorable safety profile and was generally 18Table of Contentswell-tolerated across a broad range of doses both in healthy volunteers and in patients with schizophrenia with a pharmacokinetic profile that supports once dailydosing. ITI-214 is the first compound in its class to successfully advance into Phase 1 clinical trials. On October 31, 2014, we entered into an agreement withTakeda terminating the Takeda License Agreement, or the Termination Agreement, pursuant to which all rights granted under the Takeda License Agreement werereturned to us. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug application, or IND, for ITI-214 to us. We intend to pursuethe development of our PDE program, including ITI-214 for the treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’sdisease, cognition in Alzheimer’s disease, cognition in schizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also beingadvanced for the treatment of various indications.Additional PDE ProgramsThere are multiple forms and isoforms of PDE with distinct roles in intracellular signaling. We have developed strong internal expertise in the design andsynthesis of inhibitors specific for individual PDE isoforms. Based on our understanding of the expression and functions of these isoforms in the CNS, we haveidentified PDE2 and PDE9 as compelling targets for drug discovery. We believe that inhibitors of these PDEs may be useful in treating neurodegeneration andbioenergetic failure in a variety of CNS diseases.Intellectual PropertyOur Patent PortfolioAs of February 1, 2016, we owned or controlled approximately 70 patent families filed in the United States and other major markets worldwide, includingapproximately 54 issued or allowed U.S. patents, 41 pending U.S. patent applications, 214 issued foreign patents, and 194 pending foreign patent applications,directed to novel compounds, formulations, methods of treatment, synthetic methods, and platform technologies.Our ITI-007 program on novel compounds for neuropsychiatric and neurodegenerative diseases includes patents exclusively in-licensed from Bristol-MyersSquibb on families of compounds, including the ITI-007 lead molecule. We have extensively characterized this lead and filed additional patent applications onpolymorphs, formulations, additional indications, derivatives and additional compounds. The ITI-007 lead molecule has composition of matter protection through2025 and additional Orange Book-listable protection to 2034. Additionally, we expect to have data exclusivity in the European Union for up to 11 years fromcommercial launch. We also have a follow-on program, directed to compounds structurally related to the ITI-007 lead, but having composition of matter protectionbeyond 2031.Our program on PDE1 inhibitors for cognition and dopamine-mediated disorders, such as Parkinson’s disease, includes patent protection for the leadmolecule, ITI-214, as well as a wide range of filings on other proprietary compounds and indications. The ITI-214 lead molecule has composition of matterprotection to 2029, with possible extensions and additional Orange Book-listable protection to 2034. Additionally, we expect to have data exclusivity in theEuropean Union for up to 11 years from commercial launch. We are also evaluating potential follow-on compounds for ITI-214 which would have patentprotection beyond 2030.We have also filed patent applications on novel proprietary targets and lead compounds for Alzheimer’s disease, which would provide compound protectionbeyond 2028 or beyond 2034, depending on which compound is ultimately selected for development.License AgreementThe Bristol-Myers Squibb License AgreementOn May 31, 2005, we entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company, or BMS, pursuant to which we hold alicense to certain patents and know-how of BMS relating to ITI-007 and other specified compounds. The agreement was amended on November 3, 2010. Thelicensed rights are 19Table of Contentsexclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS hasno right to use, develop or commercialize ITI-007 and other specified compounds in any field of use. We have the right to grant sublicenses of the rights conveyedby BMS. We are obliged under the license to use commercially reasonable efforts to develop and commercialize the licensed technology. We are also prohibitedfrom engaging in the clinical development or commercialization of specified competitive compounds.Under the agreement, we made an upfront payment of $1.0 million to BMS, a milestone payment of $1.25 million in December 2013, and a milestonepayment of $1.5 million in December 2014 following the initiation of our first Phase 3 clinical trial for ITI-007 for patients with exacerbated schizophrenia.Possible milestone payments remaining total $12.0 million. Under the agreement, we may be obliged to make other milestone payments to BMS for each licensedproduct of up to an aggregate of approximately $14.75 million. We are also obliged to make tiered single digit percentage royalty payments on sales of licensedproducts. We are obliged to pay to BMS a percentage of non-royalty payments made in consideration of any sublicense.The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of ten years after first commercialsale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration ofother government grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. Ontermination of the agreement, we may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product, includingregulatory filings, research results and other intellectual property rights.Collaboration AgreementThe Takeda Pharmaceutical License and Collaboration Agreement and Termination AgreementOn February 25, 2011, we entered into a license and collaboration agreement with Takeda Pharmaceutical Company Limited under which we agreed tocollaborate to research, develop and commercialize our proprietary compound ITI-214 and other selected compounds that selectively inhibit PDE1 for use in theprevention and treatment of human diseases. As part of the agreement, we assigned to Takeda certain patents owned by us that claim ITI-214 and granted Takedaan exclusive license to develop and commercialize compounds identified in the conduct of the research program that satisfy specified criteria. However, weretained rights to all compounds that do not meet the specified criteria and we continue to develop PDE1 inhibitors outside the scope of the agreement. Uponexecution of the agreement, Takeda made a nonrefundable payment to us.Under the terms of the agreement, we conducted a research program with an initial term of three years to identify and characterize compounds that meetcertain specified criteria sufficient for further development by Takeda. This research program ended in February 2014. We were responsible for our expensesincurred in the conduct of certain research activities specified in the research plan. Takeda agreed to reimburse us for expenses we incurred in conducting additionalresearch activities.On October 31, 2014, we entered into an agreement with Takeda terminating the Takeda License Agreement, pursuant to which all rights granted under theTakeda License Agreement were returned to us. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug application, or IND, forITI-214 to us. ITI-214 is the first compound in its class to successfully advance into Phase 1 clinical trials. We intend to pursue the development of our PDEprogram, including ITI-214 for the treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition inAlzheimer’s disease, cognition in schizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also being advanced for the treatmentof various indications. 20Table of ContentsManufacturingWe do not own or operate manufacturing facilities for the production of any of our product candidates, nor do we have plans to develop our ownmanufacturing operations in the foreseeable future. We currently rely on third-party contract manufacturers for all of our required raw materials, activepharmaceutical ingredient, or API, and finished product for our preclinical research and clinical trials, including the Phase 3 trials for ITI-007 for the treatment ofschizophrenia and the treatment of bipolar depression. We believe that we would be able to contract with other third-party contract manufacturers to obtain API ifour existing sources of API were no longer available, but there is no assurance that API would be available from other third-party manufacturers on acceptableterms, on the timeframe that our business would require, or at all. We do not have long-term agreements with our existing third-party contract manufacturers. Wealso do not have any current contractual relationships for the manufacture of commercial supplies of any of our product candidates if they are approved. As ITI-007and any of our other product candidates continue to progress towards potential regulatory approval, we intend to enter into agreements with a third-party contractmanufacturer and one or more back-up manufacturers for the commercial production of those products. Development and commercial quantities of any productsthat we develop will need to be manufactured in facilities, and by processes, that comply with the requirements of the FDA and the regulatory agencies of otherjurisdictions in which we are seeking approval. We currently employ internal resources to manage our manufacturing contractors.Sales and MarketingWe currently have no marketing, sales or distribution capabilities. In order to commercialize any of our product candidates, we must develop thesecapabilities internally or through collaboration with third parties. In selected therapeutic areas where we feel that our product candidates can be commercialized bya specialty sales force that calls on a limited and focused group of physicians, we may plan to participate in the commercialization of our product candidates in theUnited States. In therapeutic areas that require a large sales force selling to a large and diverse prescribing population, we may elect to commercialize through, or incollaboration with, strategic partners. We may choose to commercialize our products in markets outside of the United States by establishing one or more strategicalliances in the future.CompetitionWe face, and will continue to face, intense competition from pharmaceutical and biotechnology companies, as well as numerous academic and researchinstitutions and governmental agencies, both in the United States and abroad. We compete, or will compete, with existing and new products being developed by ourcompetitors. Some of these competitors are pursuing the development of pharmaceuticals that target the same diseases and conditions that our research anddevelopment programs target.Even if we are successful in developing our product candidates, the resulting products would compete with a variety of established drugs in the areas of ourtargeted CNS therapeutic indications. Our potential products for the treatment of schizophrenia and bipolar disorder would compete with, among other brandedproducts, Abilify ® , marketed jointly by Bristol-Myers Squibb and Otsuka Pharmaceutical; Fanapt ® , marketed by Novartis Pharmaceuticals; Seroquel XR ® ,marketed by AstraZeneca; Invega ® , marketed by Janssen; VRAYLAR ® , marketed by Allergan, Rexulti ® marketed by Otsuka Pharmaceutical and Latuda ® ,marketed by Sunovion. In addition, our product candidates, if approved, will compete with, among other generic antipsychotic products, haloperidol, risperidone,quetiapine, olanzapine and clozapine.In addition, the companies described above and other competitors may have a variety of drugs in development or awaiting FDA approval that could reach themarket and become established before we have a product to sell. Our competitors may also develop alternative therapies that could further limit the market for anydrugs that we may develop. Many of our competitors are using technologies or methods different or similar to 21Table of Contentsours to identify and validate drug targets and to discover novel small molecule drugs. Many of our competitors and their collaborators have significantly greaterexperience than we do in the following: • identifying and validating targets; • screening compounds against targets; • preclinical and clinical trials of potential pharmaceutical products; and • obtaining FDA and other regulatory clearances.In addition, many of our competitors and their collaborators have substantially greater advantages in the following areas: • capital resources; • research and development resources; • manufacturing capabilities; and • sales and marketing.Smaller companies also may prove to be significant competitors, particularly through proprietary research discoveries and collaborative arrangements withlarge pharmaceutical and established biotechnology companies. Many of our competitors have products that have been approved by the FDA or are in advanceddevelopment. We face competition from other companies, academic institutions, governmental agencies and other public and private research organizations forcollaborative arrangements with pharmaceutical and biotechnology companies, in recruiting and retaining highly qualified scientific and management personneland for licenses to additional technologies. Our competitors, either alone or with their collaborators, may succeed in developing technologies or drugs that are moreeffective, safer, and more affordable or more easily administered than ours and may achieve patent protection or commercialize drugs sooner than us.Developments by others may render our product candidates or our technologies obsolete. Our failure to compete effectively could have a material adverse effect onour business.Government RegulationUnited States—FDA ProcessThe research, development, testing, manufacture, labeling, promotion, advertising, import and export, distribution and marketing, among other things, ofdrug products are extensively regulated by governmental authorities in the United States and other countries. In the United States, the FDA regulates drugs underthe Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations. Failure to comply with the applicable U.S. requirements may subject usto administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning letters, fines, civil penalties, product recalls, product seizures, totalor partial suspension of production or distribution, injunctions and/or criminal prosecution.Drug Approval Process. None of our drug product candidates may be marketed in the United States until the drug has received FDA approval. Such approvalcan take many years to obtain and may be rejected by the FDA at a number of steps. The steps required before a drug may be marketed in the United Statesgenerally include the following: • completion of extensive pre-clinical laboratory tests, animal studies, and formulation studies in accordance with the FDA’s Good Laboratory Practice,or GLP, regulations; • submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin; • performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each proposed indication; 22Table of Contents • submission to the FDA of an NDA after completion of all clinical trials; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the API and finished drug product areproduced and tested to assess compliance with current Good Manufacturing Practices, or cGMPs; • satisfactory completion of FDA inspections of clinical trial sites to assure that data supporting the safety and effectiveness of product candidates hasbeen generated in compliance with Good Clinical Practices; and • FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.Pre-clinical tests include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies. The conduct of the pre-clinical testsand formulation of the compounds for testing must comply with federal regulations and requirements. The results of the pre-clinical tests, together withmanufacturing information and analytical data, are submitted to the FDA as part of an IND, which must become effective before human clinical trials may begin.An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about the conduct ofthe trial, such as whether human research subjects will be exposed to an unreasonable health risk. In such a case, the IND sponsor and the FDA must resolve anyoutstanding FDA concerns or questions before clinical trials can proceed. The FDA, sponsor or an Institutional Review Board, or IRB may place a study on hold atany time during development.Clinical trials involve administration of the investigational drug to human subjects under the supervision of qualified investigators. Clinical trials areconducted under protocols detailing the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Eachprotocol must be provided to the FDA as part of a separate submission to the IND. Further, an IRB, for each medical center proposing to conduct the clinical trialmust review and approve the study protocol and informed consent information for study subjects for any clinical trial before it commences at that center, and theIRB must monitor the study until it is completed. There are also requirements governing reporting of on-going clinical trials and clinical trial results to publicregistries. Study subjects must sign an informed consent form before participating in a clinical trial.Clinical trials necessary for product approval typically are conducted in three sequential phases, but the phases may overlap. • Phase 1 usually involves the initial introduction of the investigational drug into a limited population, typically healthy humans, to evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics and pharmacologic actions, and, if possible, to gain an early indication of itseffectiveness. • Phase 2 usually involves trials in a limited patient population to (i) evaluate dosage tolerance and appropriate dosage; (ii) identify possible adverseeffects and safety risks; and (iii) evaluate preliminarily the efficacy of the drug for specific targeted indications. Multiple Phase 2 clinical trials may beconducted by the sponsor to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. • Phase 3 trials, commonly referred to as pivotal studies, are undertaken in an expanded patient population at multiple, geographically dispersed clinicaltrial centers to further evaluate clinical efficacy and test further for safety by using the drug in its final form.The FDA or an IRB may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to anunacceptable health risk. The FDA may approve an NDA for a product candidate, but require that the sponsor conduct additional clinical trials to further assess thedrug after NDA approval under a post-approval commitment. Post-approval trials are typically referred to as Phase 4 clinical trials. 23Table of ContentsDuring the development of a new drug, sponsors are given an opportunity to meet with the FDA at certain points. These points may be prior to submission ofan IND, at the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for thesponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach an agreement on the nextphase of development. Sponsors typically use the end of Phase 2 meeting to discuss their Phase 2 clinical results and present their plans for the pivotal Phase 3clinical trial that they believe will support approval of the new drug. A sponsor may request a Special Protocol Assessment, or SPA, to reach an agreement with theFDA that the protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval of the product candidate with respect toeffectiveness in the indication studied. If such an agreement is reached, it will be documented and made part of the administrative record, and it will be binding onthe FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining the safety or effectiveness of theproduct after clinical studies begin, or if the sponsor fails to follow the protocol that was agreed upon with the FDA. There is no guarantee that a study willultimately be adequate to support an approval even if the study is subject to an SPA.Concurrent with clinical trials, companies usually complete additional animal safety studies and must also develop additional information about thechemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with cGMP requirements. The manufacturingprocess must be capable of consistently producing quality batches of the drug candidate and the manufacturer must develop methods for testing the quality, purityand potency of the final drugs. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drugcandidate does not undergo unacceptable deterioration over its shelf life.Assuming successful completion of the required clinical testing, the results of pre-clinical studies and of clinical studies, together with other detailedinformation, including information on the manufacture and composition of the drug, are submitted to the FDA in the form of an NDA requesting approval tomarket the product for one or more indications. An NDA must be accompanied by a significant user fee, which is waived for the first NDA submitted by aqualifying small business. The NDA is subject to a sixty day acceptance period, and if sufficiently complete to permit substantive review, will be filed by FDA atthe end of that period. For NDAs assigned a standard review designation, the FDA’s goal is to complete its review 12 months from submission and for priorityreview NDAs, 8 months from submission. These goals can be extended by the FDA requests for additional information from the sponsor.The testing and approval process requires substantial time, effort and financial resources. The FDA will review the NDA and may deem it to be inadequate tosupport approval, and we cannot be sure that any approval will be granted on a timely basis, if at all. The FDA may also refer the application to the appropriateadvisory committee, typically a panel of clinicians, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is notbound by the recommendations of the advisory committee, but it typically follows such recommendations.Before approving an NDA, the FDA inspects the facility or the facilities at which the drug and/or its active pharmaceutical ingredient is manufactured andwill not approve the product unless the manufacturing is in compliance with cGMPs. If the FDA evaluates the NDA and the manufacturing facilities are deemedacceptable, the FDA may issue an approval letter, or in some cases a Complete Response Letter. The approval letter authorizes commercial marketing of the drugfor specific indications. As a condition of NDA approval, the FDA may require post-marketing testing and surveillance to monitor the drug’s safety or efficacy, orimpose other conditions. A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval. AComplete Response Letter may require additional clinical data and/or additional clinical trial(s), and/or other significant, expensive and time-consumingrequirements related to clinical trials, pre-clinical studies or manufacturing. Even if such additional information is submitted, the FDA may ultimately decide thatthe NDA does not satisfy the criteria for approval. Data from clinical trials is not always conclusive and the FDA may interpret data differently than we or ourcollaborators interpret data. 24Table of ContentsAlternatively, the FDA could also approve the NDA with a Risk Evaluation and Mitigation Strategy to mitigate risks of the drug, which could include medicationguides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools.Once the FDA approves a drug, the FDA may withdraw product approval if on-going regulatory requirements are not met or if safety problems occur after theproduct reaches the market. In addition, the FDA may require testing, including Phase 4 clinical trials, and surveillance programs to monitor the safety effects ofapproved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs or other information.Post-Approval Requirements. After a drug has been approved by the FDA for sale, the FDA may require that certain post-approval requirements be satisfied,including the conduct of additional clinical studies. In addition, certain changes to an approved product, such as adding new indications, making certainmanufacturing changes, or making certain additional labeling claims, are subject to further FDA review and approval. Before a company can market products foradditional indications, it must obtain additional approvals from the FDA, typically a new NDA. Obtaining approval for a new indication generally requires thatadditional clinical studies be conducted. A company cannot be sure that any additional approval for new indications for any product candidate will be approved ona timely basis, or at all.If post-approval conditions are not satisfied, the FDA may withdraw its approval of the drug. In addition, holders of an approved NDA are required to(i) report certain adverse reactions to the FDA and maintain pharmacovigilance programs to proactively look for these adverse events; (ii) comply with certainrequirements concerning advertising and promotional labeling for their products; and (iii) continue to have quality control and manufacturing procedures conformto cGMPs after approval. The FDA periodically inspects the sponsor’s records related to safety reporting and/or manufacturing facilities, which includesassessment of on-going compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and qualitycontrol to maintain cGMP compliance. We intend to use third-party manufacturers to produce our products in clinical and commercial quantities, and future FDAinspections may identify compliance issues at the facilities of our contract manufacturers that may disrupt production or distribution, or require substantialresources to correct. In addition, discovery of problems with a product after approval may result in restrictions on a product, manufacturer or holder of an approvedNDA, including recall of the product from the market or withdrawal of approval of the NDA for that drug.Patent Term Restoration and Marketing Exclusivity. Depending upon the timing, duration and specifics of FDA approval of the use of our drugs, some of ourU.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during productdevelopment and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 yearsfrom the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date ofan NDA, plus the time between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible forthe extension and the extension must be requested prior to expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves theapplication for any patent term extension or restoration. In the future, we intend to apply for restorations of patent term for some of our currently owned or licensedpatents to add patent life beyond their current expiration date, depending on the expected length of clinical trials and other factors involved in the submission of therelevant NDA.Data and market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a five-year period of non-patent data exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity. A drug is a newchemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for theaction of the drug substance. During the exclusivity period, the FDA may 25Table of Contentsnot accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug wherethe applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if itcontains a certification of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA orsupplement to an existing NDA if new clinical investigations, other than bioavailability studies, conducted or sponsored by the applicant are deemed by the FDA tobe essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only theconditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing theoriginal active agent. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDAwould be required to conduct, or obtain a right of reference to all of the pre-clinical studies, adequate and well-controlled clinical trials necessary to demonstratesafety and effectiveness.Foreign RegulationIn addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales anddistribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval by the comparable regulatory authorities of foreigncountries before we can commence clinical trials and approval of foreign countries or economic areas, such as the European Union, before we may market productsin those countries or areas. The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement varygreatly from place to place, and the time may be longer or shorter than that required for FDA approval.Pricing and ReimbursementIn the United States and internationally, sales of products that we market in the future, and our ability to generate revenues on such sales, are dependent, insignificant part, on the availability of adequate coverage and reimbursement from third-party payors, such as state and federal governments, managed careproviders and private insurance plans. Private insurers, such as health maintenance organizations and managed care providers, have implemented cost-cutting andreimbursement initiatives and likely will continue to do so in the future. These include establishing formularies that govern the drugs and biologics that will beoffered and the out-of-pocket obligations of member patients for such products. We may need to conduct pharmacoeconomic studies to demonstrate the cost-effectiveness of our products for formulary coverage and reimbursement. Even with such studies, our products may be considered less safe, less effective or lesscost-effective than existing products, and third-party payors may not provide coverage and reimbursement for our product candidates, in whole or in part.In addition, particularly in the United States and increasingly in other countries, we are required to provide discounts and pay rebates to state and federalgovernments and agencies in connection with purchases of our products that are reimbursed by such entities. It is possible that future legislation in the UnitedStates and other jurisdictions could be enacted to potentially impact reimbursement rates for the products we are developing and may develop in the future andcould further impact the levels of discounts and rebates paid to federal and state government entities. Any legislation that impacts these areas could impact, in asignificant way, our ability to generate revenues from sales of products that, if successfully developed, we bring to market.Political, economic and regulatory influences are subjecting the health care industry in the United States to fundamental changes. There have been, and weexpect there will continue to be, legislative and regulatory proposals to change the health care system in ways that could significantly affect our future business. Forexample, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, the ACA,enacted in March 2010, substantially changes the way health care is financed by both governmental and private insurers. Among other cost containment measures,ACA establishes: • an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents; 26Table of Contents • a new Medicare Part D coverage gap discount program, in which pharmaceutical manufacturers who wish to have their drugs covered under Part Dmust offer discounts to eligible beneficiaries during their coverage gap period, or the donut hole; and • a new formula that increases the rebates a manufacturer must pay under the Medicaid Drug Rebate Program.In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted, which, among other things, reduceMedicare payments to providers by up to 2% per fiscal year.Sales and MarketingThe FDA regulates all advertising and promotion activities for products under its jurisdiction prior to and after approval, including standards and regulationsfor direct-to-consumer advertising, dissemination of off-label information, industry-sponsored scientific and educational activities and promotional activitiesinvolving the Internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there areany modifications to the drug, including changes in indications, labeling, or manufacturing processes or facilities, we may be required to submit and obtain FDAapproval of a new or supplemental NDA, which may require us to collect additional data or conduct additional pre-clinical studies and clinical trials. Failure tocomply with applicable FDA requirements may subject a company to adverse publicity, enforcement action by the FDA, corrective advertising, consent decreesand the full range of civil and criminal penalties available to the FDA.Physicians may prescribe legally available drugs for uses that are not described in the drug’s labeling and that differ from those tested by us and approved bythe FDA. Such off-label uses are common across medical specialties, and often reflect a physician’s belief that the off-label use is the best treatment for the patient.The FDA does not regulate the behavior of physicians in their choice of treatments, but FDA regulations do impose stringent restrictions on manufacturers’communications regarding off-label uses. Failure to comply with applicable FDA requirements may subject a company to adverse publicity, enforcement action bythe FDA, corrective advertising, consent decrees and the full range of civil and criminal penalties available to the FDA.Outside the United States, our ability to market a product is contingent upon obtaining marketing authorization from the appropriate regulatory authorities.The requirements governing marketing authorization, pricing and reimbursement vary widely from country to country.We may also be subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws.Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration in exchange for, or to induce, the referralof business, including the purchase or prescription of a particular drug. Due to the breadth of the statutory provisions, the absence of guidance in the form ofregulations, and very few court decisions addressing industry practices, it is possible that our practices might be challenged under anti-kickback or similar laws.False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented, for payment to third-party payors (including Medicare andMedicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medicallyunnecessary items or services. Our activities relating to the sale and marketing of our products may be subject to scrutiny under these laws.Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, the possibility ofexclusion from federal health care programs (including Medicare and Medicaid) and corporate integrity agreements, which impose, among other things, rigorousoperational and monitoring requirements on companies. Similar sanctions and penalties also may be imposed upon executive officers and employees, includingcriminal sanctions against executive officers under the so-called “responsible corporate officer” doctrine, even in situations where the executive officer did notintend to violate the law and 27Table of Contentswas unaware of any wrongdoing. Given the penalties that may be imposed on companies and individuals if convicted, allegations of such violations often result insettlements even if the company or individual being investigated admits no wrongdoing. Settlements often include significant civil sanctions, including fines andcivil monetary penalties, and corporate integrity agreements. If the government was to allege or convict us or our executive officers of violating these laws, ourbusiness could be harmed. In addition, private individuals have the ability to bring similar actions. Our activities could be subject to challenge for the reasonsdiscussed above and due to the broad scope of these laws and the increasing attention being given to them by law enforcement authorities. Further, there are anincreasing number of state laws that require manufacturers to make reports to states on pricing and marketing information. Many of these laws contain ambiguitiesas to what is required to comply with the laws. Given the lack of clarity in laws and their implementation, our reporting actions could be subject to the penaltyprovisions of the pertinent state authorities.Description of the MergerPursuant to an Agreement and Plan of Merger dated August 23, 2013, or the Merger Agreement, by and among Oneida Resources Corp., which we refer toas the Company, we, our and us; ITI, Inc., a Delaware corporation and wholly-owned subsidiary of the Company, or Merger Sub; and Intra-Cellular Therapies,Inc., a Delaware corporation, which we refer to as ITI; Merger Sub merged with and into ITI, with ITI remaining as the surviving entity and a wholly-ownedoperating subsidiary of the Company. This transaction is referred to throughout this report as the “Merger.” The Merger was effective on August 29, 2013, upon thefiling of a Certificate of Merger with the Secretary of State of the State of Delaware. In connection with the Merger, ITI changed its name to ITI, Inc. and OneidaResources Corp. assumed the name Intra-Cellular Therapies, Inc. The Merger was accounted for as a capital transaction. Upon the effectiveness of the Merger, theCompany’s business became the operation of ITI and its business.At the effective time of the Merger, or the Effective Time, the legal existence of Merger Sub ceased and each share of ITI common stock and each share ofITI preferred stock that was issued and outstanding immediately prior to the Effective Time was automatically exchanged for 0.5 shares of our common stock,which we refer to as the Exchange. Immediately following the Effective Time, we completed the closing of a redemption of 5,000,000 shares of our common stock,or the Redemption, from our then-current sole stockholder, which constituted all of the issued and outstanding shares of our capital stock, on a fully-diluted basis,immediately prior to the Merger. Upon completion of the Merger and the Redemption, the former stockholders of ITI held 100% of the outstanding shares of ourcapital stock. Unless otherwise indicated in this report, all share and per share figures reflect the exchange of each share of ITI common stock and each share of ITIpreferred stock then outstanding for 0.5 shares of our common stock at the Effective Time.EmployeesAs of February 15, 2016, we employed 39 employees, 37 of whom were full-time. We consider our relations with our employees to be good. To successfullydevelop our drug candidates, we must be able to attract and retain highly skilled personnel. We anticipate hiring additional employees for research anddevelopment, clinical and regulatory affairs and general and administrative activities over the next few years. In addition, we intend to use clinical researchorganizations and third parties to perform our clinical studies and manufacturing. 28Table of ContentsItem 1A.RISK FACTORSExcept for the historical information contained herein, this report contains forward-looking statements that involve risks and uncertainties. These statementsinclude projections about our finances, plans and objectives for the future, future operating and economic performance and other statements regarding futureperformance. These statements are not guarantees of future performance or events. Our actual results could differ materially from those discussed in this report.Factors that could cause or contribute to these differences include, but are not limited to, those discussed in the following section, as well as those discussed inPart II, Item 7 entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere throughout this report.You should consider carefully the following risk factors, together with all of the other information included or incorporated by reference in this report. If anyof the following risks, either alone or taken together, or other risks not presently known to us or that we currently believe to not be significant, develop into actualevents, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of ourcommon stock could decline, and stockholders may lose all or part of their investment.Risks Related to Our BusinessWe currently do not have, and may never have, any products that generate significant revenues.We have a limited operating history on which to evaluate our business and prospects. To date, we have not generated any product revenues from our productcandidates currently in development. We cannot guarantee that any of our product candidates currently in development will ever become marketable products.We must demonstrate that our drug candidates satisfy rigorous standards of safety and efficacy for their intended uses before the FDA and other regulatoryauthorities in the European Union and elsewhere will approve them for commercialization. Significant additional research, preclinical testing and clinical testing isrequired before we can file applications with the FDA or other regulatory authorities for premarket approval of our drug candidates. In addition, to competeeffectively, our drugs must be easy to administer, cost-effective and economical to manufacture on a commercial scale. We may not achieve any of theseobjectives. In September 2015, we announced top-line results from our first Phase 3 clinical trial of our most advanced drug candidate, ITI-007, in schizophrenia.We also initiated enrollment of our second Phase 3 clinical trial of ITI-007 in schizophrenia in the second quarter of 2015 and, subject to timely enrollment, weanticipate that top-line results from this trial will be available in mid-2016. In addition, all rights with respect to ITI-214, which has advanced into Phase 1 clinicaltrials that we previously granted to Takeda were recently returned to us in connection with the termination of the Takeda License Agreement. On September 15,2015, Takeda completed the transfer of the IND for ITI-214 to us. We intend to pursue the development of our PDE program, including ITI-214 for the treatment ofseveral CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease, cognition in schizophrenia and inother non-CNS indications. We cannot be certain that the clinical development of these or any other drug candidates in preclinical testing or clinical developmentwill be successful, that we will receive the regulatory approvals required to commercialize them or that any of our other research and drug discovery programs willyield a drug candidate suitable for investigation through clinical trials. Our commercial revenues from our product candidates currently in development, if any, willbe derived from sales of drugs that will not become marketable for several years, if at all.There is no guarantee that our planned clinical trials for ITI-007 in schizophrenia or in other indications will be successful.In our Phase 1 and Phase 2 clinical trials, our lead product candidate, ITI-007, has demonstrated improved sleep maintenance, antipsychotic efficacy, andclinical signals consistent with reduction in negative symptoms associated with schizophrenia, depression and anxiety, and other symptoms associated withimpaired social 29Table of Contentsfunction. In September 2015, we announced top-line clinical results from our first randomized, double-blind, placebo-controlled Phase 3 clinical trial in patientswith an acutely exacerbated episode of schizophrenia. In this trial, a once-daily 60 mg dose of ITI-007 met the primary endpoint and demonstrated antipsychoticefficacy with statistically significant superiority over placebo at week 4 (study endpoint). In addition, the 60 mg dose of ITI-007 met the key secondary endpoint ofstatistically significant improvement on the CGI-S. We are currently planning confirmatory later-stage clinical trials and recently initiated enrollment of our secondPhase 3 clinical trial of ITI-007 in schizophrenia in the second quarter of 2015. In addition, we initiated our bipolar depression program in the third quarter of 2015.The historical rate of failures for product candidates in clinical development and late-stage clinical trials is high. While we plan to conduct further clinicaltrials in patients with schizophrenia and other indications, there is no guarantee that we will have the same level of success in these trials as we have had in ourearlier clinical trials, or be successful at all.In addition, although we believe that ITI-007 and follow-on compounds may also have clinical utility in indications other than schizophrenia, such asbehavioral disturbances in dementia, bipolar disorder, intermittent explosive disorder, non-motor disorders associated with Parkinson’s disease, obsessivecompulsive disorder and anxiety disorders and post-traumatic stress disorder, we have never tested ITI-007 in Phase 2 clinical trials in the patient population forthese other indications, except for ITI-007-200, a Phase 1/2 clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of ITI-007in healthy geriatric subjects and in patients with dementia, including Alzheimer’s disease, for which we announced top-line data in the fourth quarter of 2014.If we do not successfully complete clinical development of ITI-007, we will be unable to market and sell products derived from it and to generate productrevenues. Even if we do successfully complete clinical trials for ITI-007 in patients with schizophrenia, those results are not necessarily predictive of results offuture pivotal trials that may be needed before we may submit an NDA to the FDA for the initial or other future indications. Of the vast number of drugs indevelopment, only a small percentage result in the submission of an NDA to the FDA, and even less result in the NDA ultimately being approved by the FDA forcommercialization.We have recently completed our first Phase 3 clinical trial of ITI-007 for the treatment of schizophrenia and are proceeding with our second Phase 3 clinicaltrial of ITI-007 for the treatment of schizophrenia. Although we have discussed our clinical development plans with the FDA, the agency may ultimatelydetermine that our Phase 3 clinical trials and non-clinical studies, even if successfully completed, are not sufficient for regulatory approval. If we are requiredto conduct additional clinical trials and non-clinical studies, our development of ITI-007 for schizophrenia will be more time-consuming and costly than wepresently anticipate, which would have a material adverse effect on our business, results of operations and financial condition.In June 2014, we held our end-of-Phase 2 meeting with the FDA to discuss our plans for initiating Phase 3 clinical trials of ITI-007 in schizophrenia.Following this meeting, we proceeded with our Phase 3 development program, in which we recently completed the first of two randomized, double-blind, placebo-controlled Phase 3 clinical trials of ITI-007 in patients with acutely exacerbated schizophrenia, with 450 patients enrolled in the first Phase 3 clinical trial and over600 patients planned to be enrolled in the second Phase 3 clinical trial. We completed enrollment of the first Phase 3 clinical trial in schizophrenia in the secondquarter of 2015 and initiated enrollment of the second Phase 3 clinical trial in schizophrenia in the second quarter of 2015. In the first Phase 3 trial, we randomizedpatients to two doses of ITI-007 (60mg or 40mg) or placebo over a 4-week treatment duration, and the primary outcome measure is change from baseline to Day 28on the PANSS total score. In the second Phase 3 trial, we are randomizing patients to receive one of four treatments: 60 mg ITI-007, 20 mg ITI-007, 4 mgrisperidone (active control) or placebo in a 1:1:1:1 ratio. The second Phase 3 trial is being conducted for a 6-week treatment duration. We announced top-lineresults of the first Phase 3 clinical trial of ITI-007 in patients with schizophrenia in September 2015 and anticipate that the results of the second Phase 3 clinicaltrial will be available, subject to timely enrollment, in mid-2016. Even though we believe that our recently completed Phase 3 trial and our on-going Phase 3clinical trial and ongoing and planned clinical and 30Table of Contentsnon-clinical studies for ITI-007 in schizophrenia, if successful, will be sufficient to support our NDA, the FDA may not agree with one or more aspects of ourclinical trial designs, including the duration of the trials, clinical endpoints, controls, dose ranges, collection of safety data, or adequacy of our non-clinical studies.If we submit an NDA and the FDA does not agree with our clinical and non-clinical designs, our development of ITI-007 in schizophrenia and other indicationsmay be delayed, and we may incur additional costs and devote additional resources to address any concerns the FDA may have with our trial designs. In addition,we may be required to conduct additional clinical trials or studies, which could result in additional delays and costs. There is no assurance that we will complete thePhase 3 trials and other clinical and non-clinical studies within the timeframes and the costs that we currently expect, or at all, or in a manner that is acceptable tothe FDA. Any delays or unplanned costs resulting from our Phase 3 clinical trials of ITI-007 in schizophrenia may have a material adverse effect on our business,results of operations and financial condition. Even if we eventually complete Phase 3 clinical testing, submit an NDA and receive approval of ITI-007, the FDAmay grant approval contingent on the performance of costly additional post-approval clinical trials. The FDA may also approve ITI-007 for a more limitedindication or a narrower patient population than we originally requested, and the FDA may not approve the labeling that we believe is necessary or desirable for thesuccessful commercialization of ITI-007 or our other product candidates. Any delay in obtaining, or inability to obtain, applicable regulatory approval for ITI-007would delay or prevent commercialization of ITI-007 and would materially adversely impact our business, results of operations and financial condition.We expect our net losses to continue for at least several years and are unable to predict the extent of future losses or when we will become profitable, if ever.We have experienced significant net losses since our inception. As of December 31, 2015, we had an accumulated deficit of approximately $193.0 million.We expect to incur net losses over the next several years as we advance our programs and incur significant clinical development costs. We have not received, anddo not expect to receive for at least the next several years, any revenues from the commercialization of our product candidates. Substantially all of our revenues todate were from our license and collaboration agreement with Takeda and our agreements with various U.S. governmental agencies and other parties, including ourresearch and development grants. In October 2014, we entered into the Takeda Termination Agreement, which terminated our license and collaboration agreementwith Takeda, pursuant to which all rights with respect to ITI-214 that we previously granted to Takeda were returned to us. We will not, therefore, receive anyfurther milestone payments from Takeda and we cannot be certain that we will enter into additional collaboration agreements. To obtain revenues from our productcandidates, we must succeed, either alone or with others, in developing, obtaining regulatory approval for, and manufacturing and marketing drugs with significantmarket potential. We may never succeed in these activities, and may never generate revenues that are significant enough to achieve profitability.We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay,limit, reduce or cease our operations.We have consumed substantial amounts of capital since our inception. Our cash, cash equivalents and investment securities totaled $475.2 million atDecember 31, 2015, which includes net proceeds of approximately $121.8 million from the public offering of shares of our common stock in March 2015 andapproximately $327.4 million from the public offering of shares of our common stock in September 2015. While we believe that our existing cash, cash equivalentsand investment securities, together with interest on cash balances, will be sufficient to fund our operating expenses and capital expenditure requirements throughthe end of 2018, the amount and timing of our actual expenditures will depend upon numerous factors, including the ongoing status of our second Phase 3 clinicaltrials of ITI-007 in patients with acute exacerbated schizophrenia and bipolar depression, the continued development of our PDE program, including ITI-214 for thetreatment of several CNS and non-CNS conditions, and our other planned clinical and non-clinical trials. Furthermore, we anticipate that we will need to secureadditional funding to obtain regulatory approval for ITI-007 in patients with dementia, including Alzheimer’s disease, for further development of ITI-007 inpatients with bipolar disorder, depressive disorders and other indications, and for development of our other product candidates. 31Table of ContentsIf the FDA requires that we perform additional preclinical studies or clinical trials, or we experience delays or other setbacks in our clinical trials, our expenseswould further increase beyond what we currently expect and the anticipated timing of any potential NDA would likely be delayed.With the remaining proceeds from our public offerings in February 2014, March 2015 and September 2015, we intend to fund the following: the completionof two Phase 3 clinical trials of ITI-007 in patients with acute exacerbated schizophrenia, one of which we announced top-line results in September 2015 and thesecond of which we initiated enrollment in the second quarter of 2015; the initiation of other planned clinical and non-clinical trials, including manufacturing,needed for anticipated regulatory approval of ITI-007 in patients with acute exacerbated schizophrenia and other potential additional indications; pre-launchactivities for ITI-007 for the treatment of schizophrenia and, if it receives regulatory approval, to fund our initial commercialization efforts; the completion of ourclinical trials of ITI-007 in bipolar disorder as a monotherapy and as an adjunctive therapy with lithium or valproate, a program we initiated in the third quarter of2015; clinical trials of ITI-007 for the treatment of behavioral disturbances in dementia; pre-clinical and clinical development of our ITI-007 long acting injectabledevelopment program; other clinical trials of ITI-007; the continued clinical development of our PDE1 program, including ITI-214; and research and preclinicaldevelopment of our other product candidates and the continuation of manufacturing activities in connection with the development of ITI-007. The remainingproceeds, if any, will be used to fund new and ongoing research and development activities, new business opportunities, general corporate purposes, includinggeneral and administrative expenses, capital expenditures and working capital. Accordingly, we will continue to require substantial additional capital beyond thenet proceeds from these offerings to continue our clinical development and commercialization activities. Because successful development of our product candidatesis uncertain, we are unable to estimate the actual funds we will require to complete research and development and commercialize our products under development.Our future capital requirements will depend on, and could increase significantly as a result of, many factors, including: • the progress in, and the costs of, our preclinical studies and clinical trials and other research and development programs; • the scope, prioritization and number of our research and development programs; • the ability of any future collaborators and us to reach the milestones, and other events or developments, triggering payments under any futurecollaboration agreements or to otherwise make payments under such agreements; • our ability to enter into new, and to maintain any existing, collaboration and license agreements; • the extent to which any future collaborators are obligated to reimburse us for clinical trial costs under any future collaboration agreements; • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; • the costs of securing manufacturing arrangements for clinical or commercial production; • the costs of preparing applications for regulatory approvals for our product candidates; • the costs of preparing for and establishing, or contracting for, sales and marketing capabilities if we obtain regulatory clearances to market our productcandidates; and • the costs associated with litigation.Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through our existing cash, cash equivalents and investmentsecurities, strategic collaborations, private or public sales of our securities, debt financings, grant funding, or by licensing all or a portion of our product candidatesor technology. Turmoil and volatility in the financial markets have adversely affected the market capitalizations of 32Table of Contentsmany biotechnology companies, and generally made equity and debt financing more difficult to obtain. This, coupled with other factors, may limit our access toadditional financing. This could have a material adverse effect on our ability to access sufficient funding. We cannot be certain that additional funding will beavailable to us on acceptable terms, or at all. If we do obtain additional funding through equity offerings, the ownership of our existing stockholders and purchasersof shares of our common stock in any such offering will be diluted, and the terms of any financing may adversely affect the rights of our stockholders. In addition,the issuance of additional shares by us, or the possibility of such issuance, may cause the market price of our shares to decline. If funds are not available, we will berequired to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts. We also could berequired to seek funds through arrangements with collaboration partners or otherwise that may require us to relinquish rights to some of our technologies or productcandidates or otherwise agree to terms unfavorable to us.Our management has broad discretion over the use of our cash and we may not use our cash effectively, which could adversely affect our results of operations.Our management has significant flexibility in applying our cash resources, including the net proceeds from our public offerings completed in February2014, March 2015 and September 2015, and could use these resources for corporate purposes that do not increase our market value, or in ways with which ourstockholders may not agree. We may use our cash resources for corporate purposes that do not yield a significant return or any return at all for our stockholders,which could adversely affect our future growth prospects.Our lead product candidate, ITI-007, is only part way through the clinical trials we anticipate needing to complete before we may be able to submit an NDA tothe FDA. Clinical trials are long, expensive and unpredictable, and there is a high risk of failure.Preclinical testing and clinical trials are long, expensive and unpredictable processes that can be subject to delays. It may take several years to complete thepreclinical testing and clinical development necessary to commercialize a drug, and delays or failure can occur at any stage. Interim results of clinical trials do notnecessarily predict final results, and success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. A number ofcompanies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after promising results in earliertrials.In connection with clinical trials, we face risks that a product candidate may not prove to be efficacious; patients may die or suffer other adverse effects forreasons that may or may not be related to the product candidate being tested; the results may not confirm the positive results of our earlier preclinical studies andclinical trials; and the results may not meet the level of statistical significance required by the FDA or other regulatory agencies. If we do not successfully completepreclinical and clinical development, we will be unable to market and sell products derived from our product candidates and to generate product revenues. Even ifwe do successfully complete clinical trials, those results are not necessarily predictive of results of additional trials that may be needed before an NDA may besubmitted to the FDA or the FDA may approve the NDA.Delays, suspensions and terminations in our clinical trials could result in increased costs to us, delay our ability to generate product revenues and thereforemay have a material adverse effect on our business, results of operations and future growth prospects.The commencement of clinical trials can be delayed for a variety of reasons, including delays in: demonstrating sufficient safety and efficacy to obtainregulatory approval to commence a clinical trial; reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;manufacturing sufficient quantities of a product candidate; obtaining clearance from the FDA to commence clinical trials pursuant to an IND; obtaininginstitutional review board approval to conduct a clinical trial at a prospective clinical trial site; and patient enrollment, which is a function of many factors,including the size of the patient population, the nature of the protocol, the proximity of patients to clinical trial sites, the availability of effective treatments for therelevant disease and the eligibility criteria for the clinical trial. 33Table of ContentsOnce a clinical trial has begun, it may be delayed, suspended or terminated due to a number of factors, including: ongoing discussions with regulatoryauthorities regarding the scope or design of our clinical trials or requests by them for supplemental information with respect to our clinical trial results; failure toconduct clinical trials in accordance with regulatory requirements; lower than anticipated screening or retention rates of patients in clinical trials; serious adverseevents or side effects experienced by participants; and insufficient supply or deficient quality of product candidates or other materials necessary for the conduct ofour clinical trials.Many of these factors may also ultimately lead to denial of regulatory approval of a current or potential product candidate. If we experience delays,suspensions or terminations in a clinical trial, our costs will increase, the commercial prospects for the related product candidate will be harmed, and our ability togenerate product revenues will be delayed.Safety issues with our product candidates, or with product candidates or approved products of third parties that are similar to our product candidates, couldgive rise to delays in the regulatory approval process, restrictions on labeling or product withdrawal after approval.Problems with product candidates or approved products marketed by third parties that utilize the same therapeutic target or that belong to the sametherapeutic class as our product candidates could adversely affect the development, regulatory approval and commercialization of our product candidates. In 2012,the FDA released draft guidance recommending that prospective suicidality assessments be performed in clinical trials of any drug being developed for apsychiatric indication. Our development programs are focused on psychiatric indications. Our PDE program is a novel target and may have unexpected safetyeffects that do not appear until late in clinical development or after commercial approval. To date, none of our product candidates have experienced any serious andunexpected suspected adverse reactions that resulted in the submission of an IND safety report to the FDA; however, some approved products marketed by thirdparties for psychiatric indications that utilize different therapeutic targets or are in a different therapeutic class have experienced significant safety issues. As wecontinue the development and clinical trials of our product candidates, there can be no assurance that our product candidates will not experience significant safetyissues.Discovery of previously unknown class effect problems may prevent or delay clinical development and commercial approval of product candidates or resultin restrictions on permissible uses after their approval, including withdrawal of the medicine from the market. Many drugs acting on the CNS include boxedwarnings and precautions related to suicidal behavior or ideation, driving impairment, somnolence/sedation and dizziness, discontinuation, weight gain, non-insulindependent (type II) diabetes, cardiovascular side effects, sleep disturbances, and motor disturbances. If we or others later identify undesirable side effects caused bythe mechanisms of action or classes of our product candidates or specific product candidates: • we may be required to conduct additional clinical trials or implement a Risk Evaluation and Mitigation Strategies program prior to or followingapproval; • regulatory authorities may not approve our product candidates or, as a condition of approval, require specific warnings and contraindications; • regulatory authorities may withdraw their approval of the product and require us to take our drug off the market; • we may have limitations on how we promote our drugs; • sales of products may decrease significantly; • we may be subject to litigation or product liability claims; and • our reputation may suffer.Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase ourcommercialization costs and expenses, which, in turn, could delay or prevent us from generating significant revenues from its sale. 34Table of ContentsFinally, if the FDA determines that a drug may present a risk of substance abuse, it can recommend to the Drug Enforcement Administration that the drug bescheduled under the Controlled Substances Act. Any failure or delay in commencing or completing clinical trials or obtaining regulatory approvals for our productcandidates would delay commercialization of our product candidates, and severely harm our business and financial condition.If we seek to enter into strategic alliances for our drug candidates, but fail to enter into and maintain successful strategic alliances, we may have to reduce ordelay our drug candidate development or increase our expenditures.An important element of a biotechnology company’s strategy for developing, manufacturing and commercializing its drug candidates may be to enter intostrategic alliances with pharmaceutical companies or other industry participants to advance its programs and enable it to maintain its financial and operationalcapacity. We may face significant competition in seeking appropriate alliances. If we seek such alliances, we may not be able to negotiate alliances on acceptableterms, if at all. In addition, these alliances may be unsuccessful. On October 31, 2014, we entered into the Termination Agreement with Takeda, which terminatedthe Takeda License Agreement, pursuant to which all rights granted under the Takeda License Agreement were returned to us. If we seek such alliances and thenfail to create and maintain suitable alliances, we may have to limit the size or scope of, or delay, one or more of our drug development or research programs. If weelect to fund drug development or research programs on our own, we will have to increase our expenditures and will need to obtain additional funding, which maybe unavailable or available only on unfavorable terms.To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations andalliances.Biotechnology companies at our stage of development sometimes become dependent upon collaborative arrangements or strategic alliances to complete thedevelopment and commercialization of drug candidates, particularly after the Phase 2 stage of clinical testing. If we elect to enter into collaborative arrangements orstrategic alliances, these arrangements may place the development of our drug candidates outside our control, may require us to relinquish important rights or mayotherwise be on terms unfavorable to us.Dependence on collaborative arrangements or strategic alliances would subject us to a number of risks, including the risk that: • we may not be able to control the amount and timing of resources that our collaborators may devote to the drug candidates; • our collaborators may experience financial difficulties; • we may be required to relinquish important rights, such as marketing and distribution rights; • business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability tocomplete its obligations under any arrangement; • a collaborator could independently move forward with a competing drug candidate developed either independently or in collaboration with others,including our competitors; and • collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing ourdrug candidates.Preliminary and interim data from our clinical studies that we may announce or publish from time to time may change as more patient data become available.From time to time, we may announce or publish preliminary or interim data from our clinical studies. Preliminary and interim results of a clinical trial are notnecessarily predictive of final results. Preliminary and interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient 35Table of Contentsenrollment continues and more patient data become available. As a result, preliminary and interim data should be viewed with caution until the final data areavailable. Material adverse changes in the final data compared to the interim data could significantly harm our business prospects.We rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that prevent us fromsuccessfully commercializing our product candidates.Although we design and manage our current preclinical studies and clinical trials, we do not now have the ability to conduct clinical trials for our productcandidates on our own. In addition to our collaborators, we rely on contract research organizations, medical institutions, clinical investigators, and contractlaboratories to perform data collection and analysis and other aspects of our clinical trials. In addition, we also rely on third parties to assist with our preclinicalstudies, including studies regarding biological activity, safety, absorption, metabolism, and excretion of product candidates.Our preclinical activities or clinical trials may be delayed, suspended, or terminated if: the quality or accuracy of the data obtained by the third parties onwhom we rely is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or if for other reasons, these third parties do notsuccessfully carry out their contractual duties or fail to meet regulatory obligations or expected deadlines, or these third parties need to be replaced.If the third parties on whom we rely fail to perform, our development costs may increase, our ability to obtain regulatory approval, and consequently, tocommercialize our product candidates may be delayed or prevented altogether. We currently use several contract research organizations to perform services for ourpreclinical studies and clinical trials. While we believe that there are numerous alternative sources to provide these services, in the event that we seek suchalternative sources, we may not be able to enter into replacement arrangements without delays or incurring additional expenses.Even if we successfully complete the clinical trials of one or more of our product candidates, the product candidates may fail for other reasons.Even if we successfully complete the clinical trials for one or more of our product candidates, the product candidates may fail for other reasons, including thepossibility that the product candidates will: • fail to receive the regulatory approvals required to market them as drugs; • be subject to proprietary rights held by others requiring the negotiation of a license agreement prior to marketing; • be difficult or expensive to manufacture on a commercial scale; • have adverse side effects that make their use less desirable; or • fail to compete with product candidates or other treatments commercialized by our competitors.If we are unable to receive the required regulatory approvals, secure our intellectual property rights, minimize the incidence of any adverse side effects or failto compete with our competitors’ products, our business, financial condition, and results of operations could be materially and adversely affected.Following regulatory approval of any of our drug candidates, we will be subject to ongoing regulatory obligations and restrictions, which may result insignificant expense and limit our ability to commercialize our potential products.With regard to our drug candidates, if any, approved by the FDA or by another regulatory authority, we are held to extensive regulatory requirements overproduct manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping. Regulatory approvals may also be subjectto 36Table of Contentssignificant limitations on the indicated uses or marketing of the drug candidates. Potentially costly follow-up or post-marketing clinical studies may be required as acondition of approval to further substantiate safety or efficacy, or to investigate specific issues of interest to the regulatory authority. Previously unknown problemswith the drug candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the drug, and could includewithdrawal of the drug from the market.In addition, the law or regulatory policies governing pharmaceuticals may change. New statutory requirements may be enacted or additional regulations maybe enacted that could prevent or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or extent of adverse governmentregulation that may arise from future legislation or administrative action, either in the United States or elsewhere. If we are not able to maintain regulatorycompliance, we might not be permitted to market our drugs and our business could suffer.Our product candidates may not gain acceptance among physicians, patients, or the medical community, thereby limiting our potential to generate revenues,which will undermine our future growth prospects.Even if our product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of anyapproved product candidate by physicians, health care professionals and third-party payors, and our profitability and growth will depend on a number of factors,including: • our ability to provide acceptable evidence of safety and efficacy; • pricing and cost effectiveness, which may be subject to regulatory control; • our ability to obtain sufficient third-party insurance coverage or reimbursement; • effectiveness of our or our collaborators’ sales and marketing strategy; • relative convenience and ease of administration; • prevalence and severity of any adverse side effects; and • availability of alternative treatments.If any product candidate that we develop does not provide a treatment regimen that is at least as beneficial as the current standard of care or otherwise doesnot provide some additional patient benefit over the current standard of care, that product will not achieve market acceptance and we will not generate sufficientrevenues to achieve profitability.The failure to attract and retain skilled personnel and key relationships could impair our drug development and commercialization efforts.We are highly dependent on our senior management and key clinical development, scientific and technical personnel. Competition for these types ofpersonnel is intense. The loss of the services of any member of our senior management, clinical development, scientific or technical staff may significantly delay orprevent the achievement of drug development and other business objectives and could have a material adverse effect on our business, operating results andfinancial condition. We also rely on consultants and advisors to assist us in formulating our strategy. All of our consultants and advisors are either self-employed oremployed by other organizations, and they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations,that may affect their ability to contribute to us. We intend to expand and develop new drug candidates, and will need additional funding to grow our business. Wewill need to hire additional employees in order to continue our research and clinical trials and to market our drugs when approved. This strategy will require us torecruit additional executive management and clinical development, regulatory, scientific, technical and sales and marketing personnel. There is currently intensecompetition for skilled executives and employees with relevant clinical development, scientific, technical and sales and marketing expertise, and this competition islikely to continue. The inability to attract and retain sufficient clinical development, scientific, technical and managerial personnel, due to intense competition andour limited 37Table of Contentsresources, would limit or delay our product development efforts, which would adversely affect the development of our drug candidates and commercialization ofour potential drugs and growth of our business.We may not be able to continue or fully exploit our partnerships with outside scientific and clinical advisors, which could impair the progress of our clinicaltrials and our research and development efforts.We work with scientific and clinical advisors at academic and other institutions who are experts in the field of CNS disorders. They advise us with respect toour clinical trials. These advisors are not our employees and may have other commitments that would limit their future availability to us. If a conflict of interestarises between their work for us and their work for another entity, we may lose their services, which may impair our reputation in the industry and delay thedevelopment or commercialization of our product candidates.Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercialscale. In particular, we will need to develop a larger scale manufacturing process that is more efficient and cost-effective to commercialize ITI-007 and otherproduct candidates, which may not be successful, and which may require us to transfer our production to one or more other third-party manufacturers,potentially delaying regulatory approval and commercialization.Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercialscale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, lot consistency and timelyavailability of raw materials. There is no assurance that our manufacturers will be successful in establishing a larger-scale commercial manufacturing process forITI-007 which achieves our objectives for manufacturing capacity and cost of goods. Even if we could otherwise obtain regulatory approval for any productcandidate, there is no assurance that our manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatoryauthorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product or to meet potential future demand. If ourmanufacturers are unable to produce sufficient quantities of the approved product for commercialization, our commercialization efforts would be impaired, whichwould have an adverse effect on our business, financial condition, results of operations and growth prospects.We rely on third-party manufacturers to manufacture and supply our product candidates for us. If one of our suppliers or manufacturers fails to performadequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find new suppliers or manufacturers. We may alsoface significant delays in our clinical trials, regulatory approvals and product introductions and commercialization.We have no manufacturing facilities and have limited experience in the manufacturing of drugs or in designing drug-manufacturing processes. We havecontracted with third-party manufacturers to produce, in collaboration with us, our product candidates, including ITI-007, for clinical trials. If any of our productcandidates are approved by the FDA or other regulatory agencies for commercial sale, we may need to amend our contracts with our current manufacturers orcontract with other third parties to manufacture them in larger quantities at commercial scale. While we believe that there are alternative sources available tomanufacture our product candidates, in the event that we seek such alternative sources, we may not be able to enter into replacement arrangements without delaysor additional expenditures. We cannot estimate these delays or costs with certainty but, if they were to occur, they could cause a delay in our development andcommercialization efforts. We have not entered into a long-term agreement with our current third-party manufacturers or with any alternate suppliers. Although weintend to do so prior to any commercial launch of a product that is approved by the FDA in order to ensure that we maintain adequate supplies of commercial drugproduct, we may be unable to enter into such agreements or do so on commercially reasonable terms, which could delay a product launch or subject ourcommercialization efforts to significant supply risk. 38Table of ContentsManufacturers of our product candidates are obliged to operate in accordance with FDA-mandated current good manufacturing practices, or cGMPs. Themanufacture of pharmaceutical products in compliance with the cGMPs requires significant expertise and capital investment, including the development ofadvanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, includingdifficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualifiedpersonnel, as well as compliance with strictly enforced cGMP requirements, other federal and state regulatory requirements and foreign regulations. If ourmanufacturers were to encounter any of these difficulties or otherwise fail to comply with their obligations to us or under applicable regulations, our ability toprovide product candidates in our clinical trials would be jeopardized. Any delay or interruption in the supply of clinical trial materials could delay the completionof our clinical trials, increase the costs associated with maintaining our clinical trial programs and, depending upon the period of delay, require us to commencenew clinical trials at significant additional expense or terminate the clinical trials completely.In addition, the facilities used by our contract manufacturers or other third party manufacturers to manufacture our product candidates must be approved bythe FDA pursuant to inspections that will be conducted after we request regulatory approval from the FDA. These requirements include, among other things,quality control, quality assurance and the maintenance of records and documentation. Manufacturers of our product candidates may be unable to comply with thesecGMP requirements and with other FDA, state and foreign regulatory requirements. The FDA or similar foreign regulatory agencies may also implement newstandards at any time, or change their interpretation and enforcement of existing standards for manufacture, packaging or testing of products. We have little controlover our manufacturers’ compliance with these regulations and standards. A failure of any of our current or future contract manufacturers to establish and followcGMPs and to document their adherence to such practices may lead to significant delays in clinical trials or in obtaining regulatory approval of product candidatesor the ultimate launch of products based on our product candidates into the market. Failure by our current or future third-party manufacturers or us to comply withapplicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of the government to grant pre-marketapproval of drugs, delays, suspension or withdrawal of approvals, seizures or recalls of products, operating restrictions, and criminal prosecutions. If the safety ofany product supplied is compromised due to our manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatoryapproval for or successfully commercialize our products and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay ofclinical studies, regulatory submissions, approvals or commercialization of our product candidates, entail higher costs or impair our reputation.We will need to continue to manage our organization and we may encounter difficulties with our staffing and any future transitions, which could adverselyaffect our results of operations.We will need to manage our operations and facilities effectively in order to advance our drug development programs (including ITI-007 and ITI-214),facilitate any future collaborations, and pursue other development activities. It is possible that our infrastructure may be inadequate to support our future efforts andgrowth. In particular, we may have to develop internal sales, marketing, and distribution capabilities if we decide to market any drug that we may successfullydevelop. We may not successfully manage our operations and, accordingly, may not achieve our research, development, and commercialization goals.Our ability to generate product revenues will be diminished if our products do not receive coverage from payors or sell for inadequate prices, or if patients areunable to obtain adequate levels of reimbursement.Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associatedwith their prescription drugs. Adequate coverage and reimbursement from governmental health care programs, such as Medicare and Medicaid, and commercialpayors is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when moreestablished or lower cost therapeutic alternatives are 39Table of Contentsalready available or subsequently become available. Even if we obtain coverage for any approved products, the resulting reimbursement payment rates might not beadequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use any products we may market unless coverage is provided andreimbursement is adequate to cover a significant portion of the cost of those products.In addition, the market for any products for which we may receive regulatory approval will depend significantly on access to third-party payors’ drugformularies, or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in such formulariesoften leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuse to include a particular branded drug in theirformularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available.Third-party payors, whether foreign or domestic, governmental or commercial, are developing increasingly sophisticated methods of controlling health carecosts. In addition, in the United States, no uniform policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverageand reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming andcostly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance thatcoverage will be obtained. If we are unable to obtain coverage of, and adequate payment levels for, our products from third-party payors, physicians may limit howmuch or under what circumstances they will prescribe or administer them and patients may decline to purchase them. This in turn could affect our ability tosuccessfully commercialize any approved products and thereby adversely impact our profitability, results of operations, financial condition, and future success.In the future, if we have products that are approved, health care legislation may make it more difficult to receive revenues from those products.In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals in recent years to change thehealth care system in ways that could impact our ability to sell our products profitably. In March 2010, the Patient Protection and Affordable Care Act, as amendedby the Health Care and Education Affordability Reconciliation Act, or collectively, ACA, became law in the United States. The ACA substantially changed theway health care is financed by both governmental and private insurers and significantly affects the health care industry. Among the provisions of ACA ofimportance to our potential product candidates are the following: • imposition of an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents,apportioned among these entities according to their market share in certain government health care programs; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, retroactive to January 1, 2010, to23% and 13% of the average manufacturer price for most branded and generic drugs, respectively; • expansion of health care fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers,and enhanced penalties for noncompliance; • a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated pricesof applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to becovered under Medicare Part D; • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed careorganizations; • expansion of eligibility criteria for Medicaid programs; 40Table of Contents • expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; • requirements to report certain financial arrangements with physicians and teaching hospitals, including reporting any “payments or transfers of value”made or distributed to prescribers, teaching hospitals and other health care providers and reporting any ownership and investment interests held byphysicians and their immediate family members and applicable group purchasing organizations during the preceding calendar year; • a requirement to annually report drug samples that manufacturers and distributors provide to physicians; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along withfunding for such research.Many of the details regarding the implementation of the ACA are yet to be determined and, at this time, it remains unclear what the full effect that the ACAwill have on our business. At this time, it remains unclear whether there will be any further changes made to the ACA, whether in part or in its entirety.In addition, in many foreign countries, particularly the countries of the European Union, the pricing of prescription drugs is subject to government control. Insome non-U.S. jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing varywidely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which theirnational health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specificprice for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product onthe market. We may face competition from lower-priced products in foreign countries that have placed price controls on pharmaceutical products. In addition, theremay be importation of foreign products that compete with any products we may market, which could negatively impact our profitability.We expect that the ACA, as well as other health care reform measures that may be adopted in the future, may result in more rigorous coverage criteria and inadditional downward pressure on the price that we may receive for any approved product. Any reduction in reimbursement from Medicare or other governmentprograms may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other health care reforms mayprevent us from being able to generate revenue, attain profitability, or commercialize any products for which we receive regulatory approval.If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any products we may develop, wemay not be able to generate product revenue.We do not currently have an organization for the sales, marketing or distribution of pharmaceutical products. In order to market any products that may beapproved by the FDA, we must build our sales, marketing, managerial, and related capabilities or make arrangements with third parties to perform these criticalcommercial services. There are risks involved with both establishing our own sales, marketing, managerial and related capabilities and entering into arrangementswith third parties to perform these services. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch.If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason,we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retainor reposition our sales and marketing personnel.We also may not be successful entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on termsthat are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to selland market our 41Table of Contentsproducts effectively, which could damage our reputation. If we do not establish adequate sales, marketing, and distribution capabilities, whether independently or incollaboration with third parties, we will not be successful in commercializing our product candidates, may not be able to generate product revenue and may notbecome profitable.There are possible limitations on our use of net operating losses.As of December 31, 2015, we had net operating loss carryforwards of approximately $174.8 million to reduce any future federal and state taxable incomethrough 2035. Since we had net operating loss carryforwards as of December 31, 2015, 2014 and 2013, no excess tax benefits for the tax deductions related toshare-based awards were recognized in the statements of operations. The net operating loss carryforwards of approximately $174.8 million as of December 31,2015 will begin to expire in the year 2030 if unused. The use of our net operating loss carryforwards may be restricted due to changes in our ownership, includingas a result of our public offerings in March 2015 and September 2015.Under Section 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, substantial changes in our ownership may limit the amount ofnet operating loss carryforwards, or NOL’s, and tax credit carryforwards that could be utilized annually in the future to offset taxable income.For the year ended December 31, 2015 we performed a Section 382 ownership analysis and determined that an ownership change occurred (within themeaning of Section 382 of the Code) in 2015. Based on the analysis performed, however, we do not believe that the Section 382 annual limitation will impact ourability to utilize the tax attributes that existed as of the date of the ownership change in a material manner. If we experience an ownership change in the future, thetax benefits related to the NOLs and tax credit carryforwards may be further limited or lost.Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing criticalinformation or expose us to liability, which could adversely affect our business and our reputation.In the ordinary course of our business, we, our clinical research organizations and other third parties on which we rely collect and store sensitive data,including legally protected patient health information, personally identifiable information about our employees, intellectual property, and proprietary businessinformation. We manage and maintain our applications and data utilizing on-site systems. These applications and data encompass a wide variety of business criticalinformation including research and development information and business and financial information.The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devotesignificant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, ourinformation technology and infrastructure may be vulnerable to attacks by hackers, viruses, breaches, interruptions due to employee error, malfeasance or otherdisruptions, lapses in compliance with privacy and security mandates, or damage from natural disasters, terrorism, war and telecommunication and electricalfailures. Any such event could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost orstolen. We have measures in place that are designed to detect and respond to such security incidents and breaches of privacy and security mandates. Any suchaccess, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, suchas the Health Insurance Portability and Accountability Act of 1996, government enforcement actions and regulatory penalties. Unauthorized access, loss ordissemination could also disrupt our operations, including our ability to conduct research and development activities, process and prepare company financialinformation, manage various general and administrative aspects of our business and damage our reputation, any of which could adversely affect our business. Forexample, the loss of clinical trial data from completed or 42Table of Contentsongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Inaddition, there can be no assurance that we will promptly detect any such disruption or security breach, if at all. To the extent that any disruption or security breachwere to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability andthe further development of our product candidates could be delayed.Risks Related to Our Intellectual PropertyOur ability to compete may be undermined if we do not adequately protect our proprietary rights.Our commercial success depends on obtaining and maintaining proprietary rights to our product candidates and technologies and their uses, as well assuccessfully defending these rights against third-party challenges. We will only be able to protect our product candidates, proprietary technologies, and their usesfrom unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them. We have patent rightsunder issued patents in many cases covering our ITI-007 and ITI-002 development programs. Nonetheless, the issued patents and patent applications covering ourprimary technology programs remain subject to uncertainty and continuous monitoring and action by us due to a number of factors, including: • we may not have been the first to make the inventions covered by our pending patent applications or issued patents; • we may not have been the first to file patent applications for our product candidates or the technologies we rely upon; • others may independently develop similar or alternative technologies or duplicate any of our technologies; • our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability; • any or all of our pending patent applications may not result in issued patents; • we may not seek or obtain patent protection in all countries that will eventually provide a significant business opportunity; • any patents issued to us or our collaborators may not provide a basis for commercially viable products, may not provide us with any competitiveadvantages or may be challenged by third parties; • our proprietary technologies may not be patentable; • others may design around our patent claims to produce competitive products which fall outside of the scope of our patents; • others may identify prior art which could invalidate our patents; and • changes to patent laws may limit the exclusivity rights of patent holders.Even if we have or obtain patents covering our product candidates or technologies, we may still be barred from making, using and selling our productcandidates or technologies because of the patent rights of others. Others have or may have filed, and in the future are likely to file, patent applications coveringcompounds, assays, genes, gene products and therapeutic products that are similar or identical to ours. There are many issued U.S. and foreign patents relating togenes, nucleic acids, polypeptides, chemical compounds or therapeutic products, and some of these may encompass reagents utilized in the identification ofcandidate drug compounds or compounds that we desire to commercialize. Numerous U.S. and foreign issued patents and pending patent applications owned byothers exist in the area of central nervous system disorders and the other fields in which we are developing products. These could materially affect our ability todevelop our product candidates or sell our products. Because patent applications can take many years to issue, there may be currently pending 43Table of Contentsapplications, unknown to us, that may later result in issued patents that our product candidates or technologies may infringe. These patent applications may havepriority over patent applications filed by us.We regularly conduct searches to identify patents or patent applications that may prevent us from obtaining patent protection for our proprietary compoundsor that could limit the rights we have claimed in our patents and patent applications. Disputes may arise regarding the ownership or inventorship of our inventions.It is difficult to determine how such disputes would be resolved. Others may challenge the validity of our patents. If our patents are found to be invalid, we will losethe ability to exclude others from making, using or selling the inventions claimed in our patents.Some of our academic institutional licensors, research collaborators and scientific advisors have rights to publish data and information to which we haverights. If we cannot maintain the confidentiality of our technology and other confidential information in connection with our collaborations, then our ability toreceive patent protection or protect our proprietary information will be impaired. Additionally, any employee whose employment with us terminates, whethervoluntarily by the employee or by us in connection with restructurings or otherwise, may seek future employment with our competitors. Although each of ouremployees is required to sign a confidentiality agreement with us at the time of hire, we cannot guarantee that the confidential nature of our proprietary informationwill be maintained in the course of such future employment. In addition, technology that we may license-in may become important to some aspects of our business.We generally will not control the patent prosecution, maintenance or enforcement of in-licensed technology.Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and maynot adequately protect our intellectual property, which could limit our ability to compete.Because we operate in the highly technical field of drug discovery and development of small molecule drugs, we rely in part on trade secret protection inorder to protect our proprietary technology and processes. However, trade secrets are difficult to protect. We enter into confidentiality and intellectual propertyassignment agreements with our corporate partners, employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors. Theseagreements generally require that the other party keep confidential and not disclose to third parties any confidential information developed by the party or madeknown to the party by us during the course of the party’s relationship with us. These agreements also generally provide that inventions conceived by the party in thecourse of rendering services to us will be our exclusive property. However, these agreements may not be honored and may not effectively assign intellectualproperty rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets is difficult, expensive and time consuming, and the outcome isunpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. The failure to obtain or maintain trade secret protectioncould adversely affect our competitive position.A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly,and an unfavorable outcome could harm our business.There is significant litigation in our industry regarding patent and other intellectual property rights. While we are not currently subject to any pendingintellectual property litigation, and are not aware of any such threatened litigation, we may be exposed to future litigation by third parties based on claims that ourproduct candidates, technologies or activities infringe the intellectual property rights of others. If our drug development activities are found to infringe any suchpatents, we may have to pay significant damages or seek licenses to such patents. We may need to resort to litigation to enforce a patent issued to us, protect ourtrade secrets or determine the scope and validity of third-party proprietary rights. From time to time, we may hire scientific personnel formerly employed by othercompanies involved in one or more areas similar to the activities conducted by us. Either we or these individuals may be subject to allegations of trade secretmisappropriation or other similar claims as a result of their prior affiliations. If we become involved in litigation, it could consume a substantial portion of ourmanagerial and financial resources, regardless of whether we win or lose. We also may not be able to afford the costs of litigation. 44Table of ContentsThe patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely tous, could negatively impact our patent position.The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. The U.S.Patent and Trademark Office’s, or USPTO’s, standards are uncertain and could change in the future. Consequently, the issuance and scope of patents cannot bepredicted with certainty. Patents, if issued, may be challenged, invalidated or circumvented. U.S. patents and patent applications may also be subject to interferenceproceedings, and U.S. patents may be subject to reexamination proceedings in the USPTO (and foreign patents may be subject to opposition or comparableproceedings in the corresponding foreign patent office), which proceedings could result in either loss of the patent or denial of the patent application or loss orreduction in the scope of one or more of the claims of the patent or patent application. Similarly, opposition or invalidity proceedings could result in loss of rightsor reduction in the scope of one or more claims of a patent in foreign jurisdictions. In addition, such interference, reexamination and opposition proceedings may becostly. Accordingly, rights under any issued patents may not provide us with sufficient protection against competitive products or processes.In addition, changes in or different interpretations of patent laws in the United States and foreign countries may permit others to use our discoveries or todevelop and commercialize our technology and products without providing any compensation to us or may limit the number of patents or claims we can obtain. Inparticular, there have been proposals to shorten the exclusivity periods available under U.S. patent law that, if adopted, could substantially harm our business. Theproduct candidates that we are developing are protected by intellectual property rights, including patents and patent applications. If any of our product candidatesbecomes a marketable product, we will rely on our exclusivity under patents to sell the compound and recoup our investments in the research and development ofthe compound. If the exclusivity period for patents is shortened, then our ability to generate revenues without competition will be reduced and our business couldbe materially adversely impacted. The laws of some countries do not protect intellectual property rights to the same extent as U.S. laws, and those countries maylack adequate rules and procedures for defending our intellectual property rights. For example, some countries, including many in Europe, do not grant patentclaims directed to methods of treating humans and, in these countries, patent protection may not be available at all to protect our product candidates. In addition,U.S. patent laws may change, which could prevent or limit us from filing patent applications or patent claims to protect our products and/or technologies or limitthe exclusivity periods that are available to patent holders. For example, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was recently signed intolaw and includes a number of significant changes to U.S. patent law. These include changes to transition from a “first-to-invent” system to a “first-to-file” systemand to the way issued patents are challenged. These changes may favor larger and more established companies that have more resources to devote to patentapplication filing and prosecution. The USPTO has been in the process of implementing regulations and procedures to administer the Leahy-Smith Act, and manyof the substantive changes to patent law associated with the Leahy-Smith Act may affect our ability to obtain, enforce or defend our patents. Accordingly, it is notclear what, if any, impact the Leahy-Smith Act will ultimately have on the cost of prosecuting our patent applications, our ability to obtain patents based on ourdiscoveries and our ability to enforce or defend our issued patents.If we fail to obtain and maintain patent protection and trade secret protection of our product candidates, proprietary technologies and their uses, we couldlose our competitive advantage and competition we face would increase, reducing our potential revenues and adversely affecting our ability to attain or maintainprofitability.Risks Related to Our IndustryWe will be subject to stringent regulation in connection with the marketing of any products derived from our product candidates, which could delay thedevelopment and commercialization of our products.The pharmaceutical industry is subject to stringent regulation by the FDA and other regulatory agencies in the United States and by comparable authorities inother countries. Neither we nor our collaborators can market a pharmaceutical product in the United States until it has completed rigorous preclinical testing andclinical trials 45Table of Contentsand an extensive regulatory clearance process implemented by the FDA. Satisfaction of regulatory requirements typically takes many years, depends upon the type,complexity and novelty of the product, and requires substantial resources. Even if regulatory approval is obtained, it may impose significant restrictions on theindicated uses, conditions for use, labeling, advertising, promotion, and/or marketing of such products, and requirements for post-approval studies, includingadditional research and development and clinical trials. These limitations may limit the size of the market for the product or result in the incurrence of additionalcosts. Any delay or failure in obtaining required approvals could have a material adverse effect on our ability to generate revenues and continue our business.Outside the United States, the ability to market a product is contingent upon receiving approval from the appropriate regulatory authorities. The requirementsgoverning the conduct of clinical trials, marketing authorization, pricing, and reimbursement vary widely from country to country. Only after the appropriateregulatory authority is satisfied that adequate evidence of safety, quality, and efficacy has been presented will it grant a marketing authorization. Approval by theFDA does not automatically lead to the approval by regulatory authorities outside the United States and, similarly, approval by regulatory authorities outside theUnited States will not automatically lead to FDA approval.Many of our competitors have greater resources and capital than us, putting us at a competitive disadvantage. If our competitors develop and market productsthat are more effective than our product candidates, they may reduce or eliminate our commercial opportunity.Competition in the pharmaceutical and biotechnology industries is intense and increasing. We face competition from pharmaceutical and biotechnologycompanies, as well as numerous academic and research institutions and governmental agencies, both in the United States and abroad. Some of these competitorshave products or are pursuing the development of drugs that target the same diseases and conditions that are the focus of our drug development programs.For example, our potential products for the treatment of schizophrenia would compete with, among other branded products, Abilify ® , marketed jointly byBristol-Myers Squibb and Otsuka Pharmaceutical, Fanapt ® , marketed by Novartis Pharmaceuticals, Seroquel XR ® , marketed by AstraZeneca, Invega ® ,marketed by Janssen, VRAYLAR ® , marketed by Allergan, Rexulti ® marketed by Otsuka Pharmaceutical and Latuda ® , marketed by Sunovion. In addition, ourproduct candidates, if approved, will compete with, among other generic antipsychotic drugs, haloperidol, risperidone, quetiapine, olanzapine and clozapine.Many of our competitors and their collaborators have significantly greater experience than we do in the following: • identifying and validating targets; • screening compounds against targets; • preclinical studies and clinical trials of potential pharmaceutical products; and • obtaining FDA and other regulatory approvals.In addition, many of our competitors and their collaborators have substantially greater capital and research and development resources, manufacturing, salesand marketing capabilities, and production facilities. Smaller companies also may prove to be significant competitors, particularly through proprietary researchdiscoveries and collaboration arrangements with large pharmaceutical and established biotechnology companies. Many of our competitors have products that havebeen approved or are in advanced development and may develop superior technologies or methods to identify and validate drug targets and to discover novel smallmolecule drugs. Our competitors, either alone or with their collaborators, may succeed in developing drugs that are more effective, safer, more affordable, or moreeasily administered than ours and may achieve patent protection or 46Table of Contentscommercialize drugs sooner than us. Our competitors may also develop alternative therapies that could further limit the market for any drugs that we may develop.Our failure to compete effectively could have a material adverse effect on our business.Any claims relating to improper handling, storage, or disposal of biological, hazardous, and radioactive materials used in our business could be costly anddelay our research and development efforts.Our research and development activities involve the controlled use of potentially harmful hazardous materials, including volatile solvents, biologicalmaterials such as blood from patients that have the potential to transmit disease, chemicals that cause cancer, and various radioactive compounds. Our operationsalso produce hazardous waste products. We face the risk of contamination or injury from the use, storage, handling or disposal of these materials. We are subject tofederal, state and local laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products. The cost ofcompliance with these laws and regulations could be significant, and current or future environmental regulations may impair our research, development, orproduction efforts. If one of our employees were accidentally injured from the use, storage, handling, or disposal of these materials, the medical costs related to hisor her treatment would be covered by our workers’ compensation insurance policy. However, we do not carry specific biological or hazardous waste insurancecoverage and our general liability insurance policy specifically excludes coverage for damages and fines arising from biological or hazardous waste exposure orcontamination. Accordingly, in the event of contamination or injury, we could be subject to criminal sanctions or fines or be held liable for damages, our operatinglicenses could be revoked, and we could be required to suspend or modify our operations and our research and development efforts.Consumers may sue us for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation.Researching, developing, and commercializing drug products entail significant product liability risks. Liability claims may arise from our and ourcollaborators’ use of products in clinical trials and the commercial sale of those products. Consumers may make these claims directly and our collaborators orothers selling these products may seek contribution from us if they receive claims from consumers. We have obtained limited product liability insurance coveragefor our clinical trials. Our product liability insurance coverage for clinical trials is currently limited to an aggregate of $30 million. As such, our insurance coveragemay not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer. Although we currently have product liability insurancethat covers our clinical trials, we will need to increase and expand this coverage as we commence larger scale trials and if our product candidates are approved forcommercial sale. This insurance may be prohibitively expensive or may not fully cover our potential liabilities. Inability to obtain sufficient insurance coverage atan acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of products that we or ourcollaborators develop. Product liability claims could have a material adverse effect on our business and results of operations. Our liability could exceed our totalassets if we do not prevail in a lawsuit from any injury caused by our drug products.Risks Related to Owning Our Common StockNumerous factors could result in substantial volatility in the trading price of our stock.During the year ended December 31, 2015, the price per share of our common stock on the NASDAQ Global Select Market has ranged from a high of$60.79 to a low of $16.29. We have several stockholders, including affiliated stockholders, who hold substantial blocks of our stock. Sales of large numbers ofshares by any of our large stockholders could adversely affect our trading price. If stockholders holding shares of our common stock sell, indicate an intention tosell, or if it is perceived that they will sell, substantial amounts of their common stock in the public market, the trading price of our common stock could decline. 47Table of ContentsIn addition, the trading price of our common stock may be highly volatile and could be subject to wide fluctuations in response to various factors, some ofwhich are beyond our control. These factors include: • timing and announcement of regulatory developments and approvals or preliminary, interim or final results of clinical trials; • actual or anticipated quarterly variation in our results of operations or the results of our competitors; • announcements of medical innovations or new products by our competitors; • issuance of new or changed securities analysts’ reports or recommendations for our stock; • developments or disputes concerning our intellectual property or other proprietary rights; • commencement of, or our involvement in, litigation; • market conditions in the biopharmaceutical industry; • any future sales of our common stock or other securities in connection with raising additional capital or otherwise; • any major change to the composition of our board of directors or management; and • general economic conditions and slow or negative growth of our markets.The stock market in general, and market prices for the securities of biotechnology companies like ours in particular, have from time to time experiencedvolatility that often has been unrelated to the operating performance of the underlying companies. These broad market and industry fluctuations may adverselyaffect the market price of our common stock, regardless of our operating performance. In several recent situations where the market price of a stock has beenvolatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders were to bring alawsuit against us, the defense and disposition of the lawsuit could be costly and divert the time and attention of our management and harm our operating results.Raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights.We will need to satisfy our future cash needs through public or private sales of our equity securities, sales of debt securities, the incurrence of debt fromcommercial lenders, strategic collaborations, licensing a portion or all of our product candidates and technology and, to a lesser extent, grant funding. To the extentthat we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and theterms may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may involve agreements thatinclude covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends. If we raiseadditional funds through collaboration and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or grant licenseson terms that are not favorable to us.The price of our common stock could be subject to volatility related or unrelated to our operations.The market price of our common stock could fluctuate substantially due to a variety of factors, including market perception of our ability to meet our growthprojections and expectations, quarterly operating results of other companies in the same industry, trading volume in our common stock, changes in generalconditions in the economy and the financial markets or other developments affecting our business and the business of others in our industry. In addition, the stockmarket itself is subject to extreme price and volume fluctuations. This volatility has had a significant effect on the market price of securities issued by manycompanies for reasons related and unrelated to their operating performance and could have the same effect on our common stock. 48Table of ContentsWe will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which couldharm our operating results.As a public company, we have incurred and will incur significant legal, accounting and other expenses, including costs associated with public companyreporting requirements. We also have incurred and will incur costs associated with current corporate governance requirements, including requirements underSection 404 and other provisions of the Sarbanes-Oxley Act, as well as rules implemented by the SEC or the NASDAQ Global Select Market or any other stockexchange or inter-dealer quotations system on which our common stock may be listed in the future. The expenses incurred by public companies for reporting andcorporate governance purposes have increased dramatically in recent years.If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which couldharm our operating results, our ability to operate our business and investors’ views of us.We are required to comply with Section 404 of the Sarbanes-Oxley Act. Section 404 of the Sarbanes-Oxley Act requires public companies to maintaineffective internal control over financial reporting. In particular, we must perform system and process evaluation and testing of our internal control over financialreporting to allow management to report on the effectiveness of our internal control over financial reporting. In addition, we are required to have our independentregistered public accounting firm attest to the effectiveness of our internal control over financial reporting beginning with this annual report on Form 10-K for thefiscal year ended December 31, 2015. Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produceaccurate financial statements on a timely basis is a costly and time-consuming effort that will need to be evaluated frequently. We currently do not have an internalaudit group, and we may need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge. Ifwe fail to maintain the effectiveness of our internal controls or fail to comply in a timely manner with the requirements of the Sarbanes-Oxley Act, or if we or ourindependent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, thiscould have a material adverse effect on our business. We could lose investor confidence in the accuracy and completeness of our financial reports, which couldhave an adverse effect on the price of our common stock and we could be subject to sanctions or investigations by NASDAQ, the SEC or other regulatoryauthorities, which would require additional financial and management resources. In addition, if our efforts to comply with new or changed laws, regulations, andstandards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legalproceedings against us and our business may be harmed.Our ability to successfully implement our business plan and comply with Section 404 requires us to be able to prepare timely and accurate financialstatements. We expect that we will need to continue to improve existing, and implement new operational and financial systems, procedures and controls to manageour business effectively. Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls, may cause ouroperations to suffer and we may be unable to conclude that our internal control over financial reporting is effective and to obtain an unqualified report on internalcontrols from our independent registered public accounting firm as required under Section 404 of the Sarbanes-Oxley Act. This, in turn, could have an adverseimpact on trading prices for our common stock, and could adversely affect our ability to access the capital markets.We are no longer an emerging growth company and are not able to take advantage of the reduced disclosure requirements applicable to emerging growthcompanies.We were an emerging growth company under the Jumpstart Our Business Startups Act, or JOBS Act, until December 31, 2015. As an emerging growthcompany, we took advantage of certain exemptions from various reporting requirements that are applicable to other public companies. On December 31, 2015, webecame a large 49Table of Contentsaccelerated filer and the reduced disclosure obligations of emerging growth companies are no longer available to us. As a result, we will need to comply with theindependent auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act beginning with this annual report on Form 10-K for the year endedDecember 31, 2015, will be required to hold a say-on-pay vote and a say-on-frequency vote at our 2016 annual meeting of stockholders, and will no longer beentitled to provide the reduced executive compensation disclosures permitted by emerging growth companies beginning with this annual report on Form 10-K forthe year ended December 31, 2015 and the proxy statement for our 2016 annual meeting of stockholders. We expect that our transition from “emerging growthcompany” to “large accelerated filer” will require additional attention from management and will result in increased costs to us, which could include higher legalfees, accounting and related fees and fees associated with investor relations activities, among others.If securities or industry analysts do not publish, or cease publishing, research or reports about us, our business or our market, or if they change theirrecommendations regarding our stock adversely, our stock price and trading volume could decline.The trading market for our common stock is and will be influenced by whether industry or securities analysts publish or continue to publish research andreports about us, our business, our market or our competitors and, to the extent analysts do publish such reports, what they publish in those reports. We may notcontinue to have or to obtain analyst coverage in the future. Any analysts that do cover us may make adverse recommendations regarding our stock, adverselychange their recommendations from time to time, and/or provide more favorable relative recommendations about our competitors. If any analyst who covers us ormay cover us in the future were to cease coverage of our company or fail to regularly publish reports on us, or if analysts fail to cover us or publish reports about usat all, we could lose, or never gain, visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.Provisions of the Delaware law, our restated certificate of incorporation and our restated bylaws may delay or prevent a takeover which may not be in the bestinterests of our stockholders.The provisions of Delaware law and our restated certificate of incorporation and restated bylaws could discourage or make it more difficult to accomplish aproxy contest or other change in our management or the acquisition of control by a holder of a substantial amount of our voting stock. It is possible that theseprovisions could make it more difficult to accomplish, or could deter, transactions that stockholders may otherwise consider to be in their best interests or in ourbest interests. These provisions are intended to enhance the likelihood of continuity and stability in the composition of our board of directors and in the policiesformulated by the board of directors and to discourage certain types of transactions that may involve an actual or threatened change of our control. These provisionsare designed to reduce our vulnerability to an unsolicited acquisition proposal and to discourage certain tactics that may be used in proxy fights. Such provisionsalso may have the effect of preventing changes in our management.We do not anticipate paying cash dividends in the foreseeable future.We currently intend to retain any future earnings for funding growth. We do not anticipate paying any dividends in the foreseeable future. As a result, youshould not rely on an investment in our securities if you require dividend income. Capital appreciation, if any, of our shares may be your sole source of gain for theforeseeable future. Moreover, you may not be able to re-sell your shares at or above the price you paid for them.CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTSThis report includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that relate tofuture events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels ofactivity, 50Table of Contentsperformance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “may,” “plan,” “potential,” “predict,” “project,”“targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions or phrases, or the negative of those expressions or phrases, are intendedto identify forward-looking statements, although not all forward-looking statements contain these identifying words. Although we believe that we have a reasonablebasis for each forward-looking statement contained in this report, we caution you that these statements are based on our projections of the future that are subject toknown and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or impliedby these forward-looking statements, to differ. The description of our Business set forth in Item 1, the Risk Factors set forth in this Item 1A and our Management’sDiscussion and Analysis of Financial Condition and Results of Operations set forth in Item 7 as well as other sections in this report, discuss some of the factors thatcould contribute to these differences. These forward-looking statements include, among other things, statements about: • the accuracy of our estimates regarding expenses, future revenues, uses of cash, capital requirements and the need for additional financing; • the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; • the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that we maydevelop, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; • our plans to research, develop and commercialize our current and future product candidates; • our collaborators’ election to pursue research, development and commercialization activities; • our ability to obtain future reimbursement and/or milestone payments from our collaborators; • our ability to attract collaborators with development, regulatory and commercialization expertise; • our ability to obtain and maintain intellectual property protection for our product candidates; • our ability to successfully commercialize our product candidates; • the size and growth of the markets for our product candidates and our ability to serve those markets; • the rate and degree of market acceptance of any future products; • the success of competing drugs that are or become available; • regulatory developments in the United States and other countries; • the performance of our third-party suppliers and manufacturers and our ability to obtain alternative sources of raw materials; • our ability to obtain additional financing; • our use of the proceeds from our securities offerings; • any restrictions on our ability to use our net operating loss carryforwards; • our exposure to investment risk, interest rate risk and capital market risk; • our expectations regarding the additional management attention and costs that will be required as we transition from an “emerging growth company”to a “large accelerated filer;” and • our ability to attract and retain key scientific or management personnel.We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance onour forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-lookingstatements 51Table of Contentswe make. We have included important cautionary statements in this report, particularly in the Risk Factors set forth in Item 1A of this Annual Report on Form 10-K, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements donot reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.You should read this report and the documents that we reference in this report and have filed as exhibits to this report completely and with the understandingthat our actual future results may be materially different from what we expect. The forward-looking statements contained in this report are made as of the date ofthis report, and we do not assume, and specifically disclaim, any obligation to update any forward-looking statements, whether as a result of new information,future events or otherwise. Item 1B.UNRESOLVED STAFF COMMENTSNone. Item 2.PROPERTIESOur headquarters are located at 430 East 29th Street, New York, New York 10016, where we occupy approximately 16,753 square feet of useable office andlaboratory space. The term of the lease, as amended, expires January 31, 2027. We also lease office space in Towson, Maryland on a month to month basis. Item 3.LEGAL PROCEEDINGSWe are not currently a party to any material legal proceedings. Item 4.MINE SAFETY DISCLOSURESNot applicable. 52Table of ContentsPART II Item 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OFEQUITY SECURITIESMarket InformationFrom December 20, 2013 through January 30, 2014, our common stock was quoted on the OTC Markets—OTCQB tier, or OTCQB, under the symbol“ITCI.” On January 31, 2014, our common stock commenced trading on the NASDAQ Global Select Market under the symbol “ITCI” and ceased being quoted onthe OTCQB. The high and low bid quotations per share of our common stock as reported by the OTCQB and the high and low sales prices per share of ourcommon stock as reported by NASDAQ for the applicable periods when the common stock was quoted on the OTCBB or listed on the NASDAQ Global SelectMarket, as applicable, since the common stock commenced public trading are set forth below: Year Ended December 31, 2015 High Low First Quarter $30.72 $16.29 Second Quarter $35.45 $19.86 Third Quarter $60.79 $21.19 Fourth Quarter $59.96 $37.75 Year Ended December 31, 2014 High Low First Quarter $21.26 $10.00 Second Quarter $19.60 $14.53 Third Quarter $19.77 $12.67 Fourth Quarter $19.00 $13.37 StockholdersAs of February 25, 2016, we had 43,202,709 outstanding shares of common stock and no outstanding shares of preferred stock. As of February 25, 2016,there were approximately 125 holders of record of our outstanding shares of common stock.DividendsWe have never paid cash dividends on any of our capital stock and we currently intend to retain our future earnings, if any, to fund the development andgrowth of our business. We do not intend to pay cash dividends to holders of our common stock in the foreseeable future.Unregistered Sales of SecuritiesNot applicable.Issuer Purchases of Equity SecuritiesNot applicable.Use of Proceeds from Registered SecuritiesOn February 5, 2014, we completed our initial public offering of 7,063,300 shares of our common stock at a price of $17.50 per share for aggregate grossproceeds of approximately $123.6 million. The offer and sale of all of the shares in the offering were registered under the Securities Act pursuant to a registrationstatement on Form S-1, which was declared effective on January 30, 2014 (File No. 333-193313), and a registration statement on Form S-1 filed pursuant to Rule462(b) promulgated under the Securities Act (File No. 333-193676). Leerink 53Table of ContentsPartners LLC and Cowen and Company, LLC acted as joint book-running managers for the offering and as representatives of the underwriters. GuggenheimSecurities, LLC and JMP Securities LLC acted as co-managers for the offering. The offering commenced on January 24, 2014 and did not terminate until the saleof all of the shares offered.We received aggregate net proceeds from the offering of approximately $115.4 million, after deducting approximately $7.4 million of underwriting discountsand commissions, and approximately $0.8 million of offering expenses payable by us. None of the underwriting discounts and commissions or other offeringexpenses were incurred or paid to our directors or officers or their associates or to persons owning 10 percent or more of our common stock or to any of ouraffiliates.As of December 31, 2015, we have used the net proceeds of the offering primarily for working capital purposes, including recurring expenses and preclinicaland clinical trial costs related to the development of ITI-007. 54Table of ContentsItem 6.SELECTED FINANCIAL DATAThe following table sets forth consolidated financial data with respect to the Company for each of the five years in the period ended December 31, 2015. Theselected financial data for each of the five years in the period ended December 31, 2015 have been derived from our audited consolidated financial statements. Theconsolidated balance sheets as of December 31, 2015 and 2014 and the related consolidated statements of operations, comprehensive loss, stockholders’ equity andcash flows for each of the three years in the period ended December 31, 2015, and the report thereon, are included elsewhere in this Annual Report on Form 10-K.The information below should be read in conjunction with the consolidated financial statements (and notes thereon) and “Management’s Discussion and Analysisof Financial Condition and Results of Operations,” included in Item 7. 2015 2014 2013 2012 2011 Statements of Operations: Revenues: License and collaboration revenue $30,659 $547,546 $2,737,002 $3,117,991 $22,327,464 Grant revenue 60,705 29,755 — — 1,034,495 Total Revenues 91,364 577,301 2,737,002 3,117,991 23,361,959 Costs and expenses: Research and development 87,718,074 21,226,345 23,027,578 15,486,476 7,654,546 General and administrative 18,187,286 10,337,679 5,976,276 4,034,925 4,612,450 Total costs and expenses 105,905,360 31,564,024 29,003,854 19,521,401 12,266,996 (Loss) Income from operations (105,813,996) (30,698,223) (26,266,852) (16,403,410) 11,094,963 Interest expense — (7,073) (612,963) (193,498) (15) Interest income 1,022,455 303,936 29,617 39,002 62,315 Income taxes (1,600) (1,600) (18,000) (32,921) (64,834) Net (Loss) Income $(104,793,141) $(30,691,460) $(26,868,198) $(16,590,827) $11,092,429 Net (Loss) Income per common share: Basic $(2.91) $(1.07) $(1.56) $(2.96) $1.98 Diluted $(2.91) $(1.07) $(1.56) $(2.96) $1.47 Weighted average number of common shares: Basic 36,069,237 28,650,067 17,260,768 5,607,539 5,601,495 Diluted 36,069,237 28,650,067 17,260,768 5,607,539 7,558,150 December 31, 2015 2014 2013 2012 2011 Balance Sheet data: Cash and cash equivalents $47,159,303 $61,325,044 $35,150,924 $15,645,528 $13,693,215 Total assets 484,103,528 131,111,769 38,449,312 19,823,680 23,594,725 Total liabilities 7,860,617 10,557,064 6,834,037 2,839,595 5,702,422 Accumulated deficit (193,049,098) (88,255,957) (57,564,497) (30,696,299) (14,105,472) Total stockholders’ equity 476,242,911 120,554,705 31,615,275 16,984,085 17,892,303 55Table of ContentsItem 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe following discussion of the financial condition and results of our operations and our wholly-owned subsidiary should be read in conjunction with thefinancial statements and the notes to those statements appearing elsewhere in this Annual Report on Form 10-K. Some of the information contained in thisdiscussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should read the Risk Factors set forth in Item 1A of this Annual Report on Form 10-K for a discussionof important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in thefollowing discussion and analysis.OverviewWe are a biopharmaceutical company focused on the discovery and clinical development of innovative, small molecule drugs that address underservedmedical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. ITI-007 isour lead drug development candidate with mechanisms of action that, we believe, may represent an effective treatment across multiple therapeutic indications. Inour pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, orDPPM, glutamatergic modulation, and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia and for thetreatment of bipolar disorder, including bipolar depression. At dopamine D2 receptors, ITI-007 has been demonstrated to have dual properties and to act as both apre-synaptic partial agonist and a post-synaptic antagonist. ITI-007 has also been demonstrated to have affinity for dopamine D1 receptors and indirectly stimulatephosphorylation of glutamatergic NMDA GluN2B receptors in a mesolimbic specific manner. We believe that this regional selectivity in brain areas thought tomediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, and dopaminergic interactions, may result in efficacy for a broad array ofsymptoms associated with schizophrenia and bipolar disorder with improved psychosocial function. The serotonin reuptake inhibition potentially allows forantidepressant activity in the treatment of schizoaffective disorder, other disorders with co-morbid depression, and/or as a stand-alone treatment for majordepressive disorder. We believe ITI-007 may also be useful for the treatment of other psychiatric and neurodegenerative disorders, particularly behavioraldisturbances associated with dementia, autism, and other CNS diseases. ITI-007 is in Phase 3 clinical development as a novel treatment for schizophrenia andbipolar depression.ITI-007 for the Treatment of SchizophreniaIn September 2015, we announced top-line clinical results from our first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia.This randomized, double-blind, placebo-controlled Phase 3 clinical trial was conducted at 12 sites in the United States with 450 patients randomized (1:1:1) toreceive either 60 mg of ITI-007, 40 mg of ITI-007 or placebo once daily in the morning for 28 days. The pre-specified primary efficacy measure was change frombaseline versus placebo at study endpoint (4 weeks) on the centrally rated Positive and Negative Syndrome Scale, or PANSS, total score. In this trial, the once-dailydose of 60 mg of ITI-007 met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at week 4 (studyendpoint) with additional improvements observed in social function. Moreover, the 60 mg dose of ITI-007 showed significant antipsychotic efficacy as early asweek 1, which was maintained at every time point throughout the entire study. ITI-007 showed a dose-related improvement in symptoms of schizophrenia with the40 mg dose approximating the trajectory of improvement seen with the 60 mg dose, but the effect with 40 mg did not reach statistical significance on the primaryendpoint. In addition, the 60 mg dose of ITI-007 met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scalefor Severity of Illness, or CGI-S. The 40 mg dose of ITI-007 also demonstrated a statistically significant improvement versus placebo on the CGI-S, though notformally tested against placebo as a key 56Table of Contentssecondary endpoint since it did not separate on the primary endpoint. Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile asevidenced by motoric, metabolic, and cardiovascular characteristics similar to placebo, and no clinically significant changes in akathisia, extrapyramidal symptoms,prolactin, body weight, glucose, insulin, or lipids.In September 2015, we also announced top-line data from an open-label positron emission tomography, or PET, study of ITI-007 examining brain occupancyof striatal D2 receptors. This study was conducted in patients diagnosed with schizophrenia who were otherwise healthy and stable with respect to their psychosis.After washout from their previous antipsychotic medication for at least two weeks, PET was used to determine target occupancy in brain regions at baseline (drug-free) and again after two weeks of once daily ITI-007 oral administration. In this trial, the 60 mg dose of ITI-007 was associated with a mean of approximately 40%striatal dopamine D 2 receptor occupancy. As predicted by preclinical and earlier clinical data, ITI-007 demonstrated antipsychotic effect at relatively low striatal D2 receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. Unlike any existing schizophrenia treatment, this dopaminereceptor phosphoprotein modulator, or DPPM, acts as a pre-synaptic partial agonist and post-synaptic antagonist at D 2 receptors. We believe this mechanism likelycontributes to the favorable safety profile of ITI-007, with reduced risk for hyperprolactinemia, akathisia, extrapyramidal symptoms, and other motoric side effects.The top-line results from our first Phase 3 clinical trial of ITI-007 confirm the earlier Phase 2 results that we announced in December 2013, in which ITI-007exhibited antipsychotic efficacy in a randomized, double-blind, placebo and active controlled clinical trial in patients with an acutely exacerbated episode ofschizophrenia. In this Phase 2 trial, 335 patients were randomized to receive one of four treatments: 60 mg of ITI-007, 120 mg of ITI-007, 4 mg of risperidone(active control) or placebo in a 1:1:1:1 ratio, orally once daily for 28 days. The primary endpoint for this clinical trial was change from baseline to Day 28 on thePANSS total score. In this study, ITI-007 met the trial’s pre-specified primary endpoint, improving symptoms associated with schizophrenia as measured by astatistically significant and clinically meaningful decrease in the PANSS total score. The trial also met key secondary outcome measures related to efficacy onPANSS subscales and safety. We are also conducting a second Phase 3 clinical trial in schizophrenia that we initiated in the second quarter of 2015, with over 600patients planned to be enrolled in the trial. In this trial, we are randomizing patients to two doses of ITI-007 (60 mg or 20 mg), risperidone (active control) orplacebo over a 6-week treatment duration, and the primary outcome measure is change from baseline to Day 42 on the PANSS total score. We expect patientenrollment will be completed in the second quarter of 2016. Subject to timely enrollment, we anticipate top-line results from the second Phase 3 clinical trial willbe available in mid-2016.In addition to our two Phase 3 clinical trials, we will need to complete other clinical and non-clinical trials and manufacturing and pre-commercializationactivities necessary to support the submission of a planned NDA for ITI-007 in schizophrenia, which we currently expect could occur in the first half of 2017.ITI-007 for the Treatment of Depressive Episodes Associated with Bipolar Disorder (Bipolar Depression)Our bipolar depression program consists of two Phase 3 multi-center, randomized, double-blind, placebo-controlled clinical trials: one to evaluate ITI-007 asa monotherapy and the other to evaluate ITI-007 as an adjunctive therapy with lithium or valproate. In each trial, approximately 550 patients with a clinicaldiagnosis of Bipolar I or Bipolar II disorder and who are experiencing a current major depressive episode will be randomized to receive one of three treatments: 60mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio orally once daily for 6 weeks. In the ITI-007-401 trial, patients will receive ITI-007 or placebo as amonotherapy. In the ITI-007-402 trial, patients will receive ITI-007 or placebo adjunctive to their existing mood stabilizer lithium or valproate. We initiated ourbipolar depression program in the third quarter of 2015.The primary endpoint for both clinical trials is change from baseline at Day 42 on the Montgomery-Åsberg Depression Rating Scale, orMADRS, total scoreversus placebo. The MADRS is a well-validated 10-item checklist that measures the ability of a drug to reduce overall severity of depressive symptoms. Individualitems 57Table of Contentsare rated by an expert clinician on a scale of 0 to 6 in which a score of 6 represents the most depressed evaluation for each item assessed. The total score rangesfrom 0 to 60. Secondary endpoints include measures of social function and quality of life that may illustrate the differentiated clinical profile of ITI-007. Safety andtolerability are also assessed in both clinical trials.Other Indications for ITI-007In the fourth quarter of 2014, we announced the top-line data from ITI-007-200, a Phase 1/2 clinical trial designed to evaluate the safety, tolerability andpharmacokinetics of low doses of ITI-007 in healthy geriatric subjects and in patients with dementia, including Alzheimer’s disease. The completion of this studymarks an important milestone in our strategy to develop low doses of ITI-007 for the treatment of behavioral disturbances associated with dementia and relateddisorders. The ITI-007-200 trial results to date indicate that ITI-007 is safe and well-tolerated across a range of low doses, has linear- and dose-relatedpharmacokinetics and improves cognition in the elderly. The most frequent adverse event was mild sedation at the higher doses. We believe these results furtherposition ITI-007 as a development candidate for the treatment of behavioral disturbances in patients with dementia and other neuropsychiatric and neurologicalconditions. We plan to initiate additional late phase clinical programs evaluating ITI-007 in patients with behavioral disturbances associated with dementia andrelated disorders, including Alzheimer’s disease, in the first half of 2016.We are also pursuing clinical development of ITI-007 for the treatment of additional CNS diseases and disorders. At the lowest doses, ITI-007 has beendemonstrated to act primarily as a potent 5-HT2A serotonin receptor antagonist. As the dose is increased, additional benefits are derived from the engagement ofadditional drug targets, including modest dopamine receptor modulation and modest inhibition of serotonin transporters. We believe that combined interactions atthese receptors may provide additional benefits above and beyond selective 5-HT2A antagonism for treating agitation, aggression and sleep disturbances indiseases that include dementia, Alzheimer’s disease, Huntington’s disease and autism spectrum disorders, while avoiding many of the side effects associated withmore robust dopamine receptor antagonism. As the dose of ITI-007 is further increased, leading to moderate dopamine receptor modulation, inhibition of serotonintransporters, and indirect glutamate modulation, these actions complement the complete blockade of 5-HT2A serotonin receptors. At a dose of 60 mg, ITI-007 hasbeen shown effective in treating the symptoms associated with schizophrenia, and we believe this higher dose range will be useful for the treatment of bipolardisorder, depressive disorders and other neuropsychiatric diseases.Given the potential utility for ITI-007 and follow-on compounds to treat these additional indications, we may investigate, either on our own or with a partner,agitation, aggression and sleep disturbances in additional diseases that include autism spectrum disorders; depressive disorder; intermittent explosive disorder; non-motor symptoms and motor complications associated with Parkinson’s disease; and post-traumatic stress disorder. We hold exclusive, worldwidecommercialization rights to ITI-007 and a family of compounds from Bristol-Myers Squibb Company pursuant to an exclusive license.Other Product CandidatesWe have a second major program called ITI-002 that has yielded a portfolio of compounds that selectively inhibits the enzyme phosphodiesterase type 1, orPDE1. We believe PDE1 helps regulate brain activity related to cognition, memory processes and movement/coordination. On February 25, 2011, we (through ourwholly owned operating subsidiary, ITI) and Takeda Pharmaceutical Company Limited, or Takeda, entered into a license and collaboration agreement, or theTakeda License Agreement, under which we agreed to collaborate to research, develop and commercialize our proprietary compound ITI-214 and other selectedcompounds that selectively inhibit PDE1 for use in the prevention and treatment of human diseases. On October 31, 2014, we entered into an agreement withTakeda terminating the Takeda License Agreement, or the Termination Agreement, pursuant to which all rights granted under the Takeda License Agreement werereturned to us. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug application, or IND, for ITI-214 to us. ITI-214 is 58Table of Contentsthe first compound in its class to successfully advance into Phase 1 clinical trials. We intend to pursue the development of our PDE program, including ITI-214 forthe treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease, cognition inschizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also being advanced for the treatment of various indications.Our pipeline also includes pre-clinical programs that are focused on advancing drugs for the treatment of schizophrenia, Parkinson’s disease, Alzheimer’sdisease and other neuropsychiatric and neurodegenerative disorders. We are also investigating the development of treatments for disease modification ofneurodegenerative disorders and non-CNS diseases.We have assembled a management team with significant industry experience to lead the discovery and development of our product candidates. Wecomplement our management team with a group of scientific and clinical advisors that includes recognized experts in the fields of schizophrenia and other CNSdisorders, including Nobel laureate, Dr. Paul Greengard, one of our co-founders.Since inception, we have devoted substantially all of our efforts and resources to our research and development activities. We have incurred significant netlosses since inception. As of December 31, 2015, our accumulated deficit was $193.0 million. We expect to continue incurring substantial losses for the nextseveral years as we continue to develop our clinical and pre-clinical drug candidates and programs. Our operating expenses are comprised of research anddevelopment expenses and general and administrative expenses.Our corporate headquarters and laboratory are located in New York, New York.Public Offerings in March 2015 and September 2015On March 11, 2015, we completed a public offering of 5,411,481 shares of our common stock at a price of $24.00 per share for aggregate gross proceeds ofapproximately $129.9 million, and net proceeds of approximately $121.8 million. On September 28, 2015, we completed a public offering of 7,935,000 shares ofour common stock at a price of $43.50 per share for aggregate gross proceeds of approximately $345.2 million and net proceeds of approximately $327.4 million.Results of OperationsRevenuesThe following discussion summarizes the key factors our management believes are necessary for an understanding of our financial statements.We have not generated any revenue from product sales to date and we do not expect to generate revenues from product sales for at least the next severalyears. Our revenues for the year ended December 31, 2015 have been from a government grant and the residual reimbursement of expenses from the terminatedTakeda License Agreement. Our revenues for the year ended December 31, 2014 have been from the terminated Takeda License Agreement and to a much lesserextent from a government grant. We will not receive any further revenue under the Takeda License Agreement, which was terminated on October 31, 2014. Wehave received and may continue to receive grants from U.S. government agencies and foundations.We do not expect any revenues that we may generate in the next several years to be significant enough to fund our operations. 59Table of ContentsExpensesThe process of researching and developing drugs for human use is lengthy, unpredictable and subject to many risks. We are unable with any certainty toestimate either the costs or the timelines in which those costs will be incurred. The clinical development of ITI-007 for the treatment of schizophrenia and for thetreatment of bipolar depression consumes and will continue to consume a large portion of our current, as well as projected, resources. We intend to pursue otherdisease indications that ITI-007 may address, but there are significant costs associated with pursuing FDA approval for those indications, which would include thecost of additional clinical trials.Our ITI-002 program has a compound, ITI-214, in Phase 1 development. We intend to pursue the development of our PDE program, including ITI-214 forthe treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease, cognition inschizophrenia and in other non-CNS indications. Our other projects are still in the pre-clinical stages, and will require extensive funding not only to complete pre-clinical testing, but to enter into and complete clinical trials. Expenditures that we incur on these projects will be subject to availability of funding in addition to thefunding required for the advancement of ITI-007. Any failure or delay in the advancement of ITI-007 could require us to re-allocate resources from our otherprojects to the advancement of ITI-007, which could have a significant material adverse impact on the advancement of these other projects and on our results ofoperations. Our operating expenses are comprised of (i) research and development expenses and (ii) general and administrative expenses. Our research anddevelopment costs are comprised of: • internal recurring costs, such as labor and fringe benefits, materials and supplies, facilities and maintenance costs; and • fees paid to external parties who provide us with contract services, such as pre-clinical testing, manufacturing and related testing, clinical trialactivities and license milestone payments.General and administrative expenses are incurred in three major categories: • salaries and related benefit costs; • patent, legal and professional costs; and • office and facilities overhead.We expect that research and development expenses will increase substantially as we proceed with our Phase 3 clinical trials for ITI-007 in patients withexacerbated schizophrenia and our Phase 3 clinical trials for ITI-007 in patients with bipolar disorder. We also expect that our general and administrative costs willincrease substantially from prior periods primarily due to costs to perform pre-product commercialization activities and the increased costs associated with being apublic reporting entity, which could include adding additional personnel. We granted options to purchase 884,703 shares of our common stock in 2015 and havegranted options to purchase an additional 347,137 shares of our common stock in January 2016. We also granted restricted stock units for 5,272 and 78,806 sharesof our common stock in December 2015 and January 2016, respectively. We will recognize expense associated with these restricted stock units and options over thenext three years in both research and development expenses and general and administrative expenses. We expect this non-cash expense to be material and affectquarter to quarter and year to date comparisons in the upcoming year. We expect to continue to grant stock options and other stock-based awards in the future,which will increase our stock-based compensation expense in future periods. 60Table of ContentsThe following table sets forth our revenues, operating expenses, interest income (expense) and income taxes expenses for the years ended December 31,2015, 2014 and 2013 (in thousands): For the Year Ended December 31, 2015 2014 2013 Revenues $91 $577 $2,737 Expenses Research and Development 87,718 21,226 23,028 General and Administrative 18,187 10,338 5,976 105,905 31,564 29,004 Interest Income (Expense) 1,022 298 (583) Income Taxes (1) (2) (18) Net Loss $(104,793) $(30,691) $(26,868) Comparison of Years Ended December 31, 2015 and December 31, 2014RevenuesRevenues decreased for the year ended December 31, 2015 as compared to the year ended December 31, 2014 by approximately $485.9 thousand, or 84%,primarily due to reimbursable costs paid to us by Takeda in 2014 under the Takeda License Agreement which terminated on October 31, 2014 with limitedreimbursements in 2015, offset by slightly higher revenue in 2015 from a government grant.Research and Development ExpensesResearch and development expenses increased for the year ended December 31, 2015 as compared to the year ended December 31, 2014 by approximately$66.5 million, or 313%. This change is due primarily to an increase of approximately $47.1 million of costs associated with outside clinical testing and an increaseof approximately $14.9 million from nonclinical testing in the year ended December 31, 2015 over the year ended December 31, 2014. The vast majority of theincrease is due to costs associated with conducting our ITI-007 Phase 3 clinical program in schizophrenia. In late 2014, we began a clinical trial of ITI-007 inpatients with schizophrenia and incurred the majority of the costs for this trial in 2015. In addition, we started our second Phase 3 clinical trial of ITI-007 in patientswith schizophrenia in June 2015 and incurred significant costs for this trial in the second half of 2015. In December 2015, we commenced our Phase 3 clinical trialsin bipolar disorder and have incurred approximately $3.6 million in costs through December 31, 2015. In 2014, we did not incur significant costs related to clinicaltrials. Amounts paid to external parties comprise a large portion of our research and development costs. In the year ended December 31, 2015, we incurredapproximately $76.8 million of costs to external parties who manufactured, tested and performed clinical trial related activities as compared to $16.3 million in theyear ended December 31, 2014. Of these external costs, approximately $76.1 million in the year ended December 30, 2015 and $16.0 million in the year endedDecember 31, 2014 were for ITI-007 related projects. The remaining amounts for each of these periods were spent on other projects. Internal costs are comprisedprimarily of labor, fringe benefits, materials, supplies and facilities and maintenance costs and were approximately $10.9 million and $5.0 million for the yearsended December 31, 2015 and 2014, respectively. The increase in these internal costs is due primarily to hiring additional research and development employees in2015 in addition to increased stock based compensation expense.As development of ITI-007 for the treatment of schizophrenia progresses, we anticipate costs for that program to increase considerably in the next severalyears as we continue to conduct Phase 3 and other clinical trials. We are also required to complete non-clinical testing to obtain FDA approval and manufacturematerial needed for clinical trial use, which includes non-clinical testing of the drug product and the creation of an inventory of drug product in anticipation ofpossible FDA approval. In addition we plan to spend increasing amounts to further our development of ITI-007 for other indications, including but not limited to,the treatment of 61Table of Contentsdepressive episodes associated with bipolar disorder (bipolar depression), for treatment of behavioral disturbances associated with dementia and related disorders,and for treating agitation, aggression and sleep disturbances in diseases that include dementia, Alzheimer’s disease, Huntington’s disease and autism spectrumdisorders, among other indications.As of December 31, 2015, we employed 24 full time personnel in our research and development group as compared to 16 full time personnel atDecember 31, 2014. We expect to hire additional staff as we increase our development efforts and grow our business in the upcoming years.We currently have several projects, in addition to ITI-007, that are in the research and development stages, including in the areas of cognitive dysfunctionand the treatment of neurodegenerative diseases, including Alzheimer’s disease, among others. We have used internal resources and incurred expenses not only inrelation to the development of ITI-007, but also in connection with these additional projects as well. We have not, however, reported these costs on a project byproject basis, as these costs are broadly spread among these projects. The external costs for these projects have been minimal and are reflected in the amountsdiscussed in this section “—Research and Development Expenses.”During previous years, we also incurred costs that were both reimbursable and non-reimbursable under the Takeda License Agreement. For the years endedDecember 31, 2015 and 2014, we incurred $30,700 and $14,000, respectively, of costs that were billable to Takeda pursuant to ongoing obligations under thetermination agreement. We do not expect to incur material costs going forward under this agreement.The research and development process necessary to develop a pharmaceutical product for commercialization is subject to extensive regulation by numerousgovernmental authorities in the United States and other countries. This process typically takes years to complete and requires the expenditure of substantialresources. The steps required before a drug may be marketed in the United States generally include the following: • completion of extensive pre-clinical laboratory tests, animal studies, and formulation studies in accordance with the FDA’s Good Laboratory Practice,or GLP, regulations; • submission to the FDA of an Investigational New Drug application, or IND, for human clinical testing, which must become effective before humanclinical trials may begin; • performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each proposed indication; • submission to the FDA of a New Drug Application, or NDA, after completion of all clinical trials; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient, orAPI, and finished drug product are produced and tested to assess compliance with current Good Manufacturing Practices, or cGMPs; • satisfactory completion of FDA inspections of clinical trial sites to assure that data supporting the safety and effectiveness of product candidates hasbeen generated in compliance with Good Clinical Practices; and • FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.The successful development of our product candidates and the approval process requires substantial time, effort and financial resources, and is uncertain andsubject to a number of risks. We cannot be certain that any of our product candidates will prove to be safe and effective, will meet all of the applicable regulatoryrequirements needed to receive and maintain marketing approval, or will be granted marketing approval on a timely basis, if at all. Data from pre-clinical studiesand clinical trials are susceptible to varying interpretations that could delay, limit or prevent regulatory approval or could result in label warnings related to orrecalls of approved products. 62Table of ContentsWe, the FDA, or other regulatory authorities may suspend clinical trials at any time if we or they believe that the subjects participating in such trials are beingexposed to unacceptable risks or if such regulatory agencies find deficiencies in the conduct of the trials or other problems with our product candidates. Other risksassociated with our product candidates are described in the section entitled “Risk Factors” in this Annual Report on Form 10-K.General and Administrative ExpensesGeneral and administrative expenses increased for the year ended December 31, 2015 as compared to the year ended December 31, 2014 by approximately$7.8 million, or 76%, primarily due to approximately $4.1 million of higher stock option expense and to a much lesser extent to increased bonus and labor costs andstate and local franchise and capital taxes. Salaries, bonuses and related benefit costs for our executive, finance and administrative functions for the years endedDecember 31, 2015 and 2014 were approximately 59% and 49%, respectively, of our total general and administrative costs. Our other general and administrativeexpenses include patent costs, legal, accounting and other professional fees and, to a lesser extent, facilities and general office-related overhead.We expect general and administrative costs to increase significantly as we hire additional staff, expand our operations, including initial preparation forpotential commercial activities, and incur additional costs associated with the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 in addition to being apublic company and complying with exchange listing and SEC requirements, including the additional complexities and related costs of our transition at the end of2015 from an “emerging growth company” to a “large accelerated filer” under the rules of the SEC. These increases could include higher legal fees, accountingfees and fees associated with investor relations activities, among others.Interest IncomeInterest income has increased to approximately $1.0 million from $304,000 for the year ended December 31, 2015 as compared to the year endedDecember 31, 2014. This increase is primarily a result of higher than average cash balances in 2015 as compared to 2014 which is due to the net offering proceedsof $121.8 million that we received in March 2015 and $327.4 million that we received in September 2015.Comparison of Years Ended December 31, 2014 and December 31, 2013RevenuesRevenue decreased for the year ended December 31, 2014 as compared to the year ended December 31, 2013 by approximately $2.2 million, or 79%, dueprimarily to the recognition in 2013 of previously deferred revenue relating to the Takeda License Agreement and lower reimbursable costs payable to us byTakeda in 2014 under the Takeda License Agreement, offset to a much lesser extent by revenue from a government grant in 2014.Research and Development ExpensesResearch and development expenses decreased for the year ended December 31, 2014 as compared to the year ended December 31, 2013 by approximately$1.8 million, or 8%. This decrease is due primarily to costs associated with outside clinical testing for our ITI-007 Phase 2 clinical trial that was completed in late2013 as compared to costs incurred in conducting our ITI-007 Phase 3 clinical trial, which began in the fourth quarter of 2014. Partially offsetting this decreasewere expenses of approximately $6.6 million incurred in 2014 as compared to $1.9 million in 2013 related to the manufacturing and other clinical and non-clinicaltesting of our ITI-007 product candidate and expenses of approximately $1.9 million related to our ITI-007-200 Phase 1/2 clinical trial in healthy geriatric anddementia patients incurred only in 2014. In addition, stock option expense increased by $1.7 million for the year ended December 31, 2014 due primarily to stockoptions granted in 2014. 63Table of ContentsThe research and development expenses incurred for amounts payable to external parties comprised a significant portion of our research and developmentexpenses during the years ended December 31, 2014 and 2013. We incurred expenses of approximately $14.8 million and $18.8 million for the years endedDecember 31, 2014 and 2013, respectively, for amounts payable to external parties who manufactured, tested and performed clinical trial activities for all of ourprojects. We spent approximately $14.4 million and $18.3 million on external costs for the development of ITI-007 for the years ended December 31, 2014 and2013, respectively. During the same periods, our internal research and development expenses for all projects were approximately $5.0 million and $3.0 million,respectively. The clinical development work related to ITI-007 requires the largest portion of our resources and, consequently, comprises the majority of ourspending. For the years ended December 31, 2014 and 2013, we incurred total expenses of $18.8 million and $20.8 million, respectively, for all ITI-007 relatedprojects and $2.4 million and $2.2 million, respectively, for all of our other projects. Total research and development expenses were approximately $21.2 millionfor the year ended December 31, 2014 as compared to $23.0 million for 2013.During 2014 and in previous years, we also incurred costs that were both reimbursable and non-reimbursable under the Takeda License Agreement. For theyear ended December 31, 2014, we incurred approximately $14,000 on direct costs that were billable to Takeda as compared to $97,000 for the year endedDecember 31, 2013.General and Administrative ExpensesGeneral and administrative expenses increased for the year ended December 31, 2014 as compared to the year ended December 31, 2013 by approximately$4.4 million, or 73%. This increase was primarily due to increased stock option expense of $1.7 million in 2014 related to options granted in 2014, and increasedlabor and related benefit costs of approximately $0.6 million, with the remainder comprised of higher professional fees, directors’ and officers’ insurance costs, andboard of directors compensation fees, which are due to the activities associated with being a public company. We expect these costs to increase significantly as weexpand our operations, including hiring of additional personnel, continue to be subject to the reporting requirements of being a public company and issue additionalequity incentive awards.Liquidity and Capital ResourcesThrough December 31, 2015, we provided funds for our operations by obtaining approximately $716.3 million of cash primarily through public and privateofferings of our common stock and other securities, grants from government agencies and foundations and payments received under the terminated Takeda LicenseAgreement. We do not believe that grant revenue will be a significant source of funding in the near future, and Takeda has limited ongoing funding obligationsfollowing the termination of the Takeda License Agreement on October 31, 2014. On March 11, 2015, we completed a public offering of 5,411,481 shares of ourcommon stock for aggregate gross proceeds of approximately $129.9 million and net proceeds of approximately $121.8 million. On September 28, 2015, wecompleted an additional public offering of 7,935,000 shares of our common stock for aggregate gross proceeds of approximately $345.2 million and net proceedsof approximately $327.4 million.As of December 31, 2015, we had a total of approximately $475.2 million in cash and cash equivalents and available-for-sale investment securities, andapproximately $6.3 million of short-term liabilities consisting entirely of liabilities from operations. Excluding the increase in net cash of approximately $121.8million and $327.4 million from the public offerings in March 2015 and September 2015, respectively, we spent approximately $103.1 million in cash foroperations and equipment and we reduced working capital by approximately $92.7 million for the year ended December 31, 2015. This use of cash was primarilyfor conducting clinical trials and non-clinical testing, including manufacturing related activities and funding recurring operating expenses. 64Table of ContentsFor the year 2016, we expect to spend between approximately $130 million and $160 million. We expect these expenditures to be due primarily to thedevelopment of ITI-007 in patients with schizophrenia, behavioral disturbances in dementia, bipolar disorder and depressive disorders, our ITI-007 long actinginjectable development program through pre-clinical and early clinical development, research and preclinical development of our other product candidates, thecontinuation of manufacturing activities in connection with the development of ITI-007, recurring expenses and costs to produce, develop and validate materials tobe used in clinical and non-clinical studies related to ITI-007, and expenses associated with our other development programs and general operations. We expect thatcash expenditures will continue to increase after 2016 as we further expand the ITI-007 clinical stage programs, the ITI-007 long acting injectable developmentprogram through pre-clinical and early clinical development; research and preclinical development of our other product candidates; the continuation ofmanufacturing, pre-commercial activities in connection with the development of ITI-007 and the early stage pre-commercial launch activities for ITI-007. Webelieve that our existing cash and cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements throughthe end of 2018.We will require significant additional financing in the future to continue to fund our operations. We believe that we have the funding in place to complete theadditional clinical and non-clinical trials, manufacturing and pre-commercialization activities needed for potential regulatory approval and commercialization ofITI-007 in patients with schizophrenia. With the remaining proceeds from our public offerings in March 2015 and September 2015, we believe that we have thefunds to complete our proposed clinical trials of ITI-007 in bipolar disorder as a monotherapy and as an adjunctive therapy with lithium or valproate. We will alsobe funding clinical trials of ITI-007 for the treatment of behavioral disturbances in dementia; preclinical and clinical development of ITI-007 long acting injectabledevelopment program; additional clinical trials of ITI-007; continued clinical development of our PDE program, including ITI-214; research and preclinicaldevelopment of our other product candidates; and the continuation of manufacturing activities in connection with the development of ITI-007. We anticipaterequiring additional funds to obtain regulatory approval for ITI-007 in patients with dementia, including Alzheimer’s disease, for further development of ITI-007 inpatients with bipolar disorder, depressive disorders and other indications, and for development of our other product candidates. We have incurred losses in everyyear since inception with the exception of 2011, when we received an up-front fee and a milestone payment related to the Takeda License Agreement. These losseshave resulted in significant cash used in operations. For the year ended December 31, 2015, we used net cash in operating activities and purchases of equipment ofapproximately $103.1 million and expect to use additional cash of between approximately $130 and $160 million through the end of 2016. While we have severalresearch and development programs underway, the ITI-007 program has advanced the furthest and will continue to consume increasing amounts of cash forconducting clinical trials and the testing and manufacturing of product material. As we continue to conduct the activities necessary to pursue FDA approval of ITI-007 and our other product candidates, we expect the amount of cash needed to fund operations to increase significantly over the next several years.With the termination of the Takeda License Agreement in October 2014, we will not receive milestone payments and only limited expense reimbursements,including patent filing costs, from Takeda and will be responsible for the costs of developing ITI-214. On September 15, 2015, Takeda completed the transfer ofthe IND for ITI-214 to us. We intend to pursue the development of our PDE1 program, including ITI-214 for the treatment of several CNS and non-CNSconditions, but we do not anticipate a significant increase in our operating expenses related to our PDE development programs through at least the first half of2016.We seek to balance the level of cash, cash equivalents and investments on hand with our projected needs and to allow us to withstand periods of uncertaintyrelative to the availability of funding on favorable terms. Until we can generate significant revenues from operations, we will need to satisfy our future cash needsthrough public or private sales of our equity securities, sales of debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing aportion or all of our product candidates and technology and, to a lesser extent, grant funding. 65Table of ContentsWe cannot be sure that future funding will be available to us when we need it on terms that are acceptable to us, or at all. We sell securities and incur debtwhen the terms of such transactions are deemed favorable to us and as necessary to fund our current and projected cash needs. The amount of funding we raisethrough sales of our common stock or other securities depends on many factors, including, but not limited to, the status and progress of our product developmentprograms, projected cash needs, availability of funding from other sources, our stock price and the status of the capital markets. Due to the volatile nature of thefinancial markets, equity and debt financing may be difficult to obtain. In addition, any unfavorable development or delay in the progress of our ITI-007 programcould have a material adverse impact on our ability to raise additional capital.To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders willbe diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may involveagreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaringdividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, strategicalliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs orproduct candidates or to grant licenses on terms that may not be favorable to us.If adequate funds are not available to us on a timely basis, we may be required to: (1) delay, limit, reduce or terminate pre-clinical studies, clinical trials orother clinical development activities for one or more of our product candidates, including our lead product candidate ITI-007, ITI-214, and our other pre-clinicalstage product candidates; (2) delay, limit, reduce or terminate our discovery research or pre-clinical development activities; or (3) enter into licenses or otherarrangements with third parties on terms that may be unfavorable to us or sell, license or relinquish rights to develop or commercialize our product candidates,technologies or intellectual property at an earlier stage of development and on less favorable terms than we would otherwise agree.Our cash is maintained in checking accounts, money market accounts, money market mutual funds, U.S. government agency securities, certificates ofdeposit, commercial paper, corporate notes and corporate bonds at major financial institutions. Due to the current low interest rates available for these instruments,we are earning limited interest income. We do not expect interest income to be a significant source of funding over the next several quarters. Our investmentportfolio has not been adversely impacted by the problems in the credit markets that have existed over the last several years, but there can be no assurance that ourinvestment portfolio will not be adversely affected in the future.In 2014, we entered into a long-term lease, which was amended in December 2015, for 16,753 square feet of useable laboratory and office space located at430 East 29th Street, New York, New York 10016. Due to the amortization of total lease payments, we have recognized $1.6 million of deferred rent in the yearended December 31, 2015. The deferred rent balance will incrementally increase over approximately the next year. We occupied these facilities as our headquartersin March 2015, replacing our previous laboratories and offices. The lease, as amended, has a term of 12 years. We expect that our facility related costs will increasemoderately as a result of leasing this facility.Off-Balance Sheet ArrangementsWe do not have any off-balance sheet arrangements. 66Table of ContentsContractual Obligations and CommitmentsTotal contractual obligations as of December 31, 2015 are summarized in the following table (in thousands): Payments Due By Period Total Less than1 Year 1-3 Years 4-5 Years More than5 Years Operating Lease Obligations $16,256 $0 $4,257 $3,138 $8,861 The table of Contractual Obligations and Commitments does not reflect that, under the License Agreement with BMS, we may be obligated to make futuremilestone payments to BMS totaling $12 million; to make other future milestone payments to BMS for each licensed product of up to an aggregate ofapproximately $14.75 million; to make tiered single digit percentage royalty payments on sales of licensed products; and to pay BMS a percentage of non-royaltypayments made in consideration of any sublicense.Critical Accounting Policies and EstimatesThe discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared inaccordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires management tomake estimates and assumptions that affect reported amounts of assets and liabilities as of the date of the balance sheet and reported amounts of revenues andexpenses for the periods presented. Judgments must also be made about the disclosure of contingent liabilities. We base our estimates on historical experience andon various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgmentsabout the carrying values of assets and liabilities that are not readily apparent from other sources. Management makes estimates and exercises judgment in revenuerecognition and stock-based compensation. Actual results may differ from those estimates and under different assumptions or conditions.We believe that the following critical accounting policies affect management’s more significant judgments and estimates used in the preparation of ourfinancial statements:Revenue RecognitionRevenue is recognized when all terms and conditions of the agreements have been met, including that persuasive evidence of an arrangement exists, deliveryhas occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. We are reimbursed for certain costs incurredon specified research projects under the terms and conditions of grants, collaboration agreements, and awards. We record the amount of reimbursement as revenueson a gross basis in accordance with ASC Topic 605-45, Revenue Recognition/Principal Agent Considerations . We are the primary obligor with respect topurchasing goods and services from third-party suppliers, are obligated to compensate the service provider for the work performed, and have discretion in selectingthe supplier. Provisions for estimated losses on research grant projects and any other contracts are made in the period such losses are determined.We have entered into arrangements involving the delivery of more than one element. Each required deliverable is evaluated to determine whether it qualifiesas a separate unit of accounting. For us, this determination is generally based on whether the deliverable has “stand-alone value” to the customer. We adopted thisaccounting standard on a prospective basis for all Multiple-Deliverable Revenue Arrangements, or MDRAs, entered into on or after January 1, 2011, and for anyMDRAs that were entered into prior to January 1, 2011, but materially modified on or after that date. 67Table of ContentsThe adoption of this accounting standard did not have a material impact on our results of operations for the years ended December 31, 2015, 2014 and 2013,or on our financial positions as of those dates.We have adopted ASC Topic 605-28, Milestone Method . Under this guidance, we recognize revenue contingent upon the achievement of a substantivemilestone in its entirety in the period the milestone is achieved. Substantive milestone payments are recognized upon achievement of the milestone only if all of thefollowing conditions are met: • the milestone payments are non-refundable; • achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • substantive effort on our part is involved in achieving the milestone; • the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and • a reasonable amount of time passes between the up-front license payment and the first milestone payment, as well as between each subsequentmilestone payment.Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, theresulting payment would not be considered a substantive milestone, and therefore, the resulting payment would be considered part of the consideration for thesingle unit of accounting and be recognized as revenue as such performance obligations are performed under either the proportional performance or straight-linemethods, as applicable. In addition, the determination that one such payment was not a substantive milestone could prevent us from concluding that subsequentmilestone payments were substantive milestones and, as a result, any additional milestone payments could also be considered part of the consideration for the singleunit of accounting and would be recognized as revenue as such performance obligations are performed under either the proportional performance or straight-linemethods, as applicable.Research and DevelopmentExcept for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, theCompany recognizes research and development expense as the services are rendered. Research and development costs primarily consist of salaries and relatedexpenses for personnel and resources and the costs of clinical trials. Other research and development expenses include preclinical analytical testing, outsideservices, providers, materials and consulting fees.Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks usingdata such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Paymentsfor these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financialstatements as prepaid or accrued research and development expense, as the case may be.As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contractswith vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms ofthese contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materialsor services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching thoseexpenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trialas measured by subject progression and the timing of various aspects of the trial. The 68Table of ContentsCompany determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to theprogress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition ifactual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstancesknown to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and otherthird-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the statusand timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high ortoo low for any particular period.Stock-Based CompensationStock-based payments in the form of options are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation .The fair value of share-based payments is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model, or the Black-Scholes model. Theresulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. Restricted stock units are valued atthe fair market value on the date of grant as determined by the closing stock price.For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. For awards that contain aperformance-based vesting condition, expense is amortized using the accelerated attribution method. Share-based compensation expense recognized in thestatements of operations for the years ended December 31, 2015, 2014 and 2013 is based on share-based awards ultimately expected to vest, and this amount hastherefore been reduced for estimated forfeitures. ASC Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequentperiods if actual forfeitures differ from those estimates. Pre-vesting forfeitures for the fiscal years ended December 31, 2015, 2014 and 2013 were estimated basedon our historical experience and have not been material.We utilize the Black-Scholes model for estimating fair value of our stock options granted. Option valuation models, including the Black-Scholes model,require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptionsinclude the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Restricted stock units are valued at the fairmarket value on the date of grant as determined by the closing stock price.Expected volatility rates are based on historical volatility of the common stock of comparable publicly traded entities and other factors due to the limitedhistorical information about our common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding.Given the limited historical exercise data, the expected life is determined using the “simplified method,” which is defined as the midpoint between the vesting dateand the end of the contractual term.The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant.We have not paid dividends to our stockholders since our inception and do not plan to pay cash dividends in the foreseeable future. Therefore, we have assumed anexpected dividend rate of zero.Prior to January 1, 2014, given that there was no active market for our common stock, the exercise price of the stock options on the date of grant wasdetermined and approved by the board of directors using several factors, including progress and milestones achieved in our business development and performance,the price per share of our convertible preferred stock offerings and general industry and economic trends. In establishing the estimated fair value of our commonstock, we considered the guidance set forth in American Institute of Certified 69Table of ContentsPublic Accountants Practice Guide, “ Valuation of Privately-Held-Company Equity Securities Issued as Compensation .” For stock options granted in 2014 and2015, the exercise price was determined by using the closing market price of our common stock on the date of grant.Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a futuretax deduction under existing tax law shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes . The deductible temporarydifference is based on the compensation cost recognized for financial reporting purposes. However, these provisions currently do not impact us, as all the deferredtax assets have a full valuation allowance.Since we had net operating loss carryforwards as of December 31, 2015, 2014 and 2013, no excess tax benefits for the tax deductions related to share-basedawards were recognized in the statements of operations.Equity instruments issued to non-employees are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-BasedPayments to Non-Employees . Accordingly, the estimated fair value of the equity instrument is recorded on the earlier of the performance commitment date or thedate the services required are completed and are marked to market during the service period.Recently Issued Accounting PronouncementsWe review new accounting standards to determine the expected financial impact, if any, that the adoption of each such standard will have.In November 2015, the FASB issued Accounting Standards Update No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of DeferredTaxes. Current GAAP requires an entity to separate deferred income tax liabilities and assets into current and noncurrent amounts in a classified statement offinancial position. To simplify the presentation of deferred income taxes, ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent ina classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset andpresented as a single amount is not affected by the amendments in this Update. The amendments in this Update are effective for financial statements issued forannual periods beginning after December 15, 2016, and interim periods within those annual periods. Earlier application is permitted for all entities as of thebeginning of an interim or annual reporting period. We have elected to adopt this update as of the fourth quarter of 2015, retrospectively. The adoption of thisstandard did not have a material impact on our consolidated financial statements and accompanying notes.In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue fromContracts with Customers. ASU 2014-09 will eliminate transaction-specific and industry-specific revenue recognition guidance under current GAAP and replace itwith a principle-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferredgoods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenueand cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain orfulfill a contract. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017, to January 1, 2018, with an option that permitscompanies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permitsthe use of either the retrospective or cumulative effect transition method. Presently, we are assessing what effect the adoption of this standard will have on ourconsolidated financial statements and accompanying notes. 70Table of ContentsItem 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKInterest Rate Sensitivity. As of December 31, 2015, we had cash, cash equivalents and marketable securities of $475.2 million consisting of cash depositedin a highly rated financial institution in the United States and in a short-term U.S. Treasury money market fund, as well as high-grade corporate bonds andcommercial paper. The primary objective of our investment activities is to preserve our capital for the purpose of funding operations and we do not enter intoinvestments for trading or speculative purposes. We believe that we do not have material exposure to high-risk investments such as mortgage-backed securities,auction rate securities or other special investment vehicles within our money-market fund investments. We believe that we do not have any material exposure tochanges in fair value as a result of changes in interest rates, although the recent rise in interest rates has resulted in our unrealized loss on investments for the yearended December 31, 2015 and 2014 totaling approximately $0.5 million and $0.1 million, respectively. Since we plan on holding those investments to maturity, norecognition of impairment is required. Declines in interest rates, however, would reduce future investment income.Capital Market Risk. We currently have no product revenues and depend on funds raised through other sources. One possible source of funding is throughfurther equity offerings. Our ability to raise funds in this manner depends upon capital market forces affecting our stock price. Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAINTRA-CELLULAR THERAPIES, INC. Index to Financial Statements and Financial Statement Schedules Number Independent Auditors’ Report F-1 Consolidated Balance Sheets as of December 31, 2015 and 2014 F-2 Consolidated Statements of Operations for the Years Ended December 31, 2015, 2014 and 2013 F-3 Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2015, 2014 and 2013 F-4 Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2015, 2014 and 2013 F-5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2015, 2014 and 2013 F-6 Notes to Consolidated Financial Statements F-7 Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENot applicable. Item 9A.CONTROLS AND PROCEDURESEvaluation of Disclosure Controls and ProceduresOur principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Form 10-K, have concluded that, based on such evaluation, our disclosurecontrols and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act isrecorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to ourmanagement, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisionsregarding required disclosure. 71Table of ContentsManagement’s Report on Internal Control over Financial ReportingThe Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financialreporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, as a process designed by, or under the supervision of, the Company’s principalexecutive and principal financial officers and effected by the Company’s board of directors, management and other personnel to provide reasonable assuranceregarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accountingprinciples. The Company’s internal control over financial reporting includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of theCompany; • provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generallyaccepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations ofmanagement and directors of the Company; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets thatcould have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance withthe policies or procedures may deteriorate.The Company’s management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2015. In making thisassessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013).Based on our assessment, management believes that, as of December 31, 2015, the company’s internal control over financial reporting is effective based onthose criteria .Our independent registered public accounting firm has issued an audit report on our assessment of our internal control over financial reporting. This reportappears further below in this Item 9A.Changes in Internal ControlsThere were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurredduring the fourth quarter of our last fiscal year that have materially affected, or are reasonably likely to materially affect, our internal control over financialreporting other than our continued improvement of documentation and other existing internal controls. This improvement included but was not limited to hiringadditional personnel, hiring an independent outside firm to aid in the controls testing and reassigning tasks to allow for greater segregation of duties.Report of Independent Registered Public Accounting FirmThe Board of Directors and Stockholders of Intra-Cellular Therapies, Inc.We have audited Intra-Cellular Therapies, Inc. and subsidiaries’ internal control over financial reporting as of December 31, 2015, based on criteriaestablished in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (theCOSO criteria). Intra-Cellular Therapies, Inc. and subsidiaries’ management is responsible for maintaining effective internal control over financial reporting, andfor its assessment of the effectiveness of internal control over financial 72Table of Contentsreporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on theCompany’s internal control over financial reporting based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all materialrespects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing andevaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessaryin the circumstances. We believe that our audit provides a reasonable basis for our opinion.A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control overfinancial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect thetransactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation offinancial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only inaccordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection ofunauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance withthe policies or procedures may deteriorate.In our opinion, Intra-Cellular Therapies, Inc. and subsidiaries maintained, in all material respects, effective internal control over financial reporting as ofDecember 31, 2015, based on the COSO criteria.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheetsof Intra-Cellular Therapies, Inc. and subsidiaries as of December 31, 2015 and 2014, and the related consolidated statements of operations, comprehensive loss,stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2015 and our report dated February 25, 2016 expressed anunqualified opinion thereon./s/ Ernst & Young LLPBaltimore, MDFebruary 25, 2016 Item 9B.OTHER INFORMATIONNot applicable. 73Table of ContentsPART III Item 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCEThe response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance,”“Section 16(a) Beneficial Ownership Reporting Compliance,” and “Code of Conduct and Ethics” in the Company’s Proxy Statement for the 2016 Annual Meetingof Stockholders. Item 11.EXECUTIVE COMPENSATIONThe response to this item is incorporated by reference from the discussion responsive thereto under the captions “Executive Officer and DirectorCompensation,” “Compensation Discussion and Analysis,” “Management and Corporate Governance – Compensation Committee Interlocks and InsiderParticipation,” “Compensation Committee Report” and “Compensation Practices and Policies Relating to Risk Management” in the Company’s Proxy Statementfor the 2016 Annual Meeting of Stockholders. Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERMATTERSThe response to this item is incorporated by reference from the discussion responsive thereto under the captions “Security Ownership of Certain BeneficialOwners and Management” and “Equity Compensation Plan Information” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders. Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe response to this item is incorporated by reference from the discussion responsive thereto under the captions “Certain Relationships and Related PersonTransactions” and “Management and Corporate Governance” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders. Item 14.PRINCIPAL ACCOUNTING FEES AND SERVICESThe response to this item is incorporated by reference from the discussion responsive thereto under the caption “Proposal 2: Ratification of Selection ofIndependent Registered Public Accounting Firm” in the Company’s Proxy Statement for the 2016 Annual Meeting of Stockholders. 74Table of ContentsPART IV Item 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULES Item 15(a).The following documents are filed as part of this annual report on Form 10-K: Item 15(a)(1) and (2)See “Index to Consolidated Financial Statements and Financial Statement Schedules” at Item 8 to this Annual Report on Form 10-K.Other financial statement schedules have not been included because they are not applicable or the information is included in thefinancial statements or notes thereto. Item 15(a)(3)ExhibitsThe following is a list of exhibits filed as part of this Annual Report on Form 10-K. Exhibit Number Exhibit Description Filed Herewith Incorporated by Reference herein from Form or Schedule Filing Date SEC File/ Reg. Number2.1 Agreement and Plan of Merger, dated as of August 23, 2013, by andamong the Registrant, ITI, Inc. and Intra-Cellular Therapies, Inc. 8-K (Exhibit 2.1) 8/29/2013 000-548962.2 Agreement and Plan of Merger, dated as of August 29, 2013, by andbetween the Registrant and Intra-Cellular Therapies, Inc., relating tothe name change of the Registrant. 8-K (Exhibit 2.2) 9/5/2013 000-548963.1 Restated Certificate of Incorporation of the Registrant, filed with theSecretary of State of the State of Delaware on November 7, 2013. S-1/A (Exhibit 3.1) 11/26/13 333-1912383.2 Certificate of Merger relating to the Merger of ITI, Inc. with andinto Intra-Cellular Therapies, Inc., filed with the Secretary of Stateof the State of Delaware on August 29, 2013. 8-K (Exhibit 3.3) 9/5/2013 000-548963.3 Certificate of Ownership and Merger relating to the Merger of Intra-Cellular Therapies, Inc. with and into the Registrant, filed with theSecretary of State of the State of Delaware on August 29, 2013,relating to the name change of the Registrant. 8-K (Exhibit 3.4) 9/5/2013 000-548963.4 Restated Bylaws of the Registrant. 8-K (Exhibit 3.5) 9/5/2013 000-548964.1 Form of common stock certificate. 8-K (Exhibit 4.1) 9/5/2013 000-548964.2 .1 Warrant to Purchase Common Stock dated April 19, 2013 issued toAlzheimer Drug Discovery Foundation, Inc. 8-K (Exhibit 4.2.1) 9/5/2013 000-54896 75Table of ContentsExhibit Number Exhibit Description Filed Herewith Incorporated by Reference herein from Form or Schedule Filing Date SEC File/ Reg. Number .2 Amendment dated August 29, 2013 to Warrant to Purchase CommonStock dated April 19, 2013 issued to Alzheimer Drug DiscoveryFoundation, Inc. 8-K (Exhibit 4.2.2) 9/5/2013 000-5489610.1 .1 License Agreement dated as of May 31, 2005 by and between Bristol-Meyers Squibb Company and Intra-Cellular Therapies, Inc.** 8-K/A (Exhibit 10.1.1) 10/31/2013 000-54896 .2 Amendment No. 1 to License Agreement dated as of November 3, 2010by and between Bristol-Meyers Squibb Company and Intra-CellularTherapies, Inc. 8-K (Exhibit 10.1.2) 9/5/2013 000-5489610.2 .1 License and Collaboration Agreement dated as of February 25, 2011 byand between Takeda Pharmaceutical Company Limited and Intra-Cellular Therapies, Inc.** 8-K/A (Exhibit 10.2) 10/31/2013 000-54896 .2 Termination Agreement dated as of October 31, 2014 by and betweenTakeda Pharmaceutical Company Limited and Intra-Cellular Therapies,Inc.† 10-K (Exhibit 10.2.2) 3/12/2015 001-3627410.3 Employment Agreement effective as of February 26, 2008 by andbetween Sharon Mates, Ph.D. and Intra-Cellular Therapies, Inc.* 8-K (Exhibit 10.3) 9/5/2013 000-5489610.4 Employment Agreement effective as of August 3, 2015 by and betweenMichael I. Halstead and Intra-Cellular Therapies, Inc..* 10-Q (Exhibit 10.1) 11/5/2015 001-3627410.5 Employment Agreement effective as of February 26, 2008 by andbetween Lawrence J. Hineline and Intra-Cellular Therapies, Inc.* 8-K (Exhibit 10.4) 9/5/2013 000-5489610.6 Employment Agreement effective as of November 4, 2015 by andbetween Robert Davis, Ph.D. and Intra-Cellular Therapies, Inc.* X 10.7 Employment Agreement effective as of November 5, 2015 by andbetween Kimberly Vanover, Ph.D. and Intra-Cellular Therapies, Inc.* X 76Table of ContentsExhibit Number Exhibit Description Filed Herewith Incorporated by Reference herein from Form or Schedule Filing Date SEC File/ Reg. Number 10.8 Employee Proprietary Information, Inventions, and Non-CompetitionAgreement effective as of September 1, 2003 by and between SharonMates, Ph.D. and Intra-Cellular Therapies, Inc.* 8-K (Exhibit 10.8) 9/5/2013 000-54896 10.9 Employee Proprietary Information, Inventions, and Non-CompetitionAgreement effective as of July 29, 2014 by and between Michael Halsteadand Intra-Cellular Therapies, Inc.* 10-K (Exhibit 10.11) 3/12/2015 001-36274 10.10 Employee Proprietary Information, Inventions, and Non-CompetitionAgreement effective as of December 1, 2003 by and between Lawrence J.Hineline and Intra-Cellular Therapies, Inc.* 8-K (Exhibit 10.9) 9/5/2013 000-54896 10.11 Employee Proprietary Information, Inventions, and Non-CompetitionAgreement effective as of November 4, 2015 by and between RobertDavis, Ph.D. and Intra-Cellular Therapies, Inc.* X 10.12 Employee Proprietary Information, Inventions, and Non-CompetitionAgreement effective as of March 5, 2007 by and between Kimberly E.Vanover, Ph.D. and Intra-Cellular Therapies, Inc.* 8-K (Exhibit 10.12) 9/5/2013 000-54896 10.13 Form of Indemnification Agreement by and between the Company and itsdirectors and executive officers.* 8-K (Exhibit 10.13) 9/5/2013 000-54896 10.14 2003 Equity Incentive Plan, as amended.* 8-K (Exhibit 10.14) 9/5/2013 000-54896 10.15 Form of Stock Option Agreement under the 2003 Equity Incentive Plan, asamended.* 8-K (Exhibit 10.15) 9/5/2013 000-54896 10.16 Amended and Restated 2013 Equity Incentive Plan.* 8-K (Exhibit 10.1) 6/18/2015 001-36274 10.17 Form of Stock Option Agreement under the 2013 Equity Incentive Plan.* 10-K (Exhibit 10.19) 3/25/2014 001-36274 10.18 Non-Employee Director Compensation Policy.* 10-Q (Exhibit 10.1) 8/12/2014 001-36274 77Table of ContentsExhibit Number Exhibit Description Filed Herewith Incorporated by Reference herein from Form or Schedule Filing Date SEC File/ Reg. Number 10.19 Redemption Agreement dated as of August 29, 2013 by and betweenthe Registrant and NLBDIT 2010 Services, LLC. 8-K (Exhibit 10.17) 9/5/2013 000-54896 10.20 Indemnity Agreement dated as of August 29, 2013 by and among theRegistrant, Intra-Cellular Therapies, Inc. and Samir N. Masri. 8-K (Exhibit 10.18) 9/5/2013 000-54896 10.21 Registration Rights Agreement dated as of August 29, 2013 by andamong Intra-Cellular Therapies, Inc., the stockholders named thereinand the Registrant. 8-K (Exhibit 10.19) 9/5/2013 000-54896 14.1 Corporate Code of Conduct and Ethics and Whistleblower Policy. X 21.1 Subsidiaries. S-1 (Exhibit 21.1) 9/18/13 333-191238 23.1 Consent of Ernst & Young LLP. X 31.1 Certification of the Chief Executive Officer. X 31.2 Certification of the Chief Financial Officer. X 32.1 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of2002. X 101 .INS XBRL Instance Document. X .SCH XBRL Taxonomy Extension Schema Document. X .CAL XBRL Taxonomy Extension Calculation Linkbase Document. X .DEF XBRL Taxonomy Extension Definition. X .LAB XBRL Taxonomy Extension Label Linkbase Document. X .PRE XBRL Taxonomy Presentation Linkbase Document. X *Management contract or compensatory plan or arrangement.**Confidential treatment has been granted for portions of this Exhibit. Redacted portions filed separately with the Securities and Exchange Commission.†Confidential treatment is being requested for portions of this Exhibit. Redacted portions filed separately with the Securities and Exchange Commission. 78Table of ContentsSIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned, thereunto duly authorized. INTRA-CELLULAR THERAPIES, INC.Date: February 25, 2016 By: /s/ Sharon Mates, Ph.D. Sharon Mates, Ph.D. Chairman, President and Chief Executive OfficerPursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrantand in the capacities indicated below and on the dates indicated. Signatures Title DateBy: /s/ Sharon Mates, Ph.D. Sharon Mates, Ph.D. Chairman, President and Chief Executive Officer (principalexecutive officer) February 25, 2016By: /s/ Lawrence J. Hineline Lawrence J. Hineline Vice President of Finance and Chief Financial Officer (principalfinancial officer and principal accounting officer) February 25, 2016By: /s/ Christopher Alafi, Ph.D. Christopher Alafi, Ph.D. Director February 25, 2016By: /s/ Richard Lerner, M.D. Richard Lerner, M.D. Director February 25, 2016By: /s/ Joel S. Marcus Joel S. Marcus Director February 25, 2016By: /s/ Rory B. Riggs Rory B. Riggs Director February 25, 2016By: /s/ Robert L. Van Nostrand Robert L. Van Nostrand Director February 25, 2016 79Table of ContentsReport of Independent Registered Public Accounting FirmThe Board of Directors and Stockholders of Intra-Cellular Therapies, Inc.We have audited the accompanying consolidated balance sheets of Intra-Cellular Therapies, Inc. and subsidiaries as of December 31, 2015 and 2014, and therelated consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31,2015. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statementsbased on our audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that weplan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, ona test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used andsignificant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basisfor our opinion.In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Intra-Cellular Therapies, Inc.and subsidiaries at December 31, 2015 and 2014, and the consolidated results of their operations and their cash flows for each of the three years in the period endedDecember 31, 2015, in conformity with U.S. generally accepted accounting principles.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Intra-Cellular Therapies, Inc.’sinternal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control-Integrated Framework issued by the Committeeof Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 25, 2016 expressed an unqualified opinion thereon./s/ Ernst & Young LLPBaltimore, MDFebruary 25, 2016 F-1Table of ContentsIntra-Cellular Therapies, Inc.Consolidated Balance Sheets December 31, 2015 2014 Assets Current assets: Cash and cash equivalents $47,159,303 $61,325,044 Investment securities, available-for-sale 428,041,021 68,320,672 Accounts receivable 30,660 51,603 Prepaid expenses and other current assets 8,025,147 1,288,953 Total current assets 483,256,131 130,986,272 Property and equipment, net 775,522 54,553 Other assets 71,875 70,944 Total assets $484,103,528 $131,111,769 Liabilities and stockholders’ equity Current liabilities: Accounts payable $1,632,905 $2,052,765 Accrued and other current liabilities 3,423,464 7,529,241 Accrued employee benefits 1,207,143 975,058 Total current liabilities 6,263,512 10,557,064 Long-term deferred rent 1,597,105 — Total liabilities 7,860,617 10,557,064 Stockholders’ equity: Common stock, $.0001 par value: 100,000,000 shares authorized; 43,155,875 and 29,499,059 shares issued andoutstanding at December 31, 2015 and 2014, respectively 4,316 2,950 Additional paid-in capital 669,878,103 208,912,345 Accumulated deficit (193,049,098) (88,255,957) Accumulated comprehensive loss (590,410) (104,633) Total stockholders’ equity 476,242,911 120,554,705 Total liabilities and stockholders’ equity $484,103,528 $131,111,769 See accompanying notes to consolidated financial statements. F-2Table of ContentsIntra-Cellular Therapies, Inc.Consolidated Statements of Operations Years Ended December 31, 2015 2014 2013 Revenues: License and collaboration revenue $30,659 $547,546 $2,737,002 Grant Revenue 60,705 29,755 — Total revenues 91,364 577,301 2,737,002 Costs and expenses: Research and development 87,718,074 21,226,345 23,027,578 General and administrative 18,187,286 10,337,679 5,976,276 Total costs and expenses 105,905,360 31,564,024 29,003,854 Loss from operations (105,813,996) (30,986,723) (26,266,852) Interest income 1,022,455 303,936 29,617 Interest expense — (7,073) (612,963) Income tax expense (1,600) (1,600) (18,000) Net loss $(104,793,141) $(30,691,460) $(26,868,198) Net loss per common share: Basic & Diluted $(2.91) $(1.07) $(1.56) Weighted average number of common shares: Basic & Diluted 36,069,237 28,650,067 17,260,768 See accompanying notes to consolidated financial statements. F-3Table of ContentsIntra-Cellular Therapies, Inc.Consolidated Statements of Comprehensive Loss Years Ended December 31, 2015 2014 2013 Net loss $(104,793,141) $(30,691,460) $(26,868,198) Other comprehensive loss: Unrealized loss on investment securities (485,777) (104,633) — Comprehensive loss $(105,278,918) $(30,796,093) $(26,868,198) See accompanying notes to consolidated financial statements. F-4Table of ContentsIntra-Cellular Therapies, Inc.Consolidated Statements of Stockholders’ Equity Common Stock Additional Paid-in Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total Stockholders’ Equity Shares Amount Balance at December 31, 2012 14,599,612 1,460 $47,678,924 $(30,696,299) $— $16,984,085 Conversion of convertible notes 110,446 11 701,712 — — 701,723 Private placement of common stock 6,916,697 692 39,962,808 — — 39,963,500 Exercise of stock options 514,466 51 332,887 — — 332,938 Stock subscription 18,225 2 109,832 — — 109,834 Share-based compensation — — 391,393 — — 391,393 Net loss — — — (26,868,198) — (26,868,198) Balance at December 31, 2013 22,159,446 $2,216 $89,177,556 $(57,564,497) $— $31,615,275 Common shares issued February 5, 2014 7,063,300 706 115,442,041 — 115,442,747 Exercise of stock options 247,165 25 162,955 — 162,980 Stock issued for services 10,923 1 176,084 176,085 Stock subscription 18,225 2 109,831 109,833 Share-based compensation — — 3,843,878 — 3,843,878 Net loss — — — (30,691,460) (30,691,460) Other comprehensive loss (104,633) (104,633) Balance at December 31, 2014 29,499,059 $2,950 $208,912,345 $(88,255,957) $(104,633) $120,554,705 Common shares issued March 11, 2015 5,411,481 541 121,803,828 — 121,804,369 Common shares issued September 28, 2015 7,935,000 793 327,435,412 — 327,436,205 Exercise of stock options 305,005 31 653,015 — 653,046 Stock issued for services 5,330 1 182,598 182,599 Share-based compensation — — 10,890,905 — 10,890,905 Net loss — — — (104,793,141) (104,793,141) Other comprehensive loss (485,777) (485,777) Balance at December 31, 2015 43,155,875 $4,316 $669,878,103 $(193,049,098) $(590,410) $476,242,911 See accompanying notes to consolidated financial statements. F-5Table of ContentsIntra-Cellular Therapies, Inc.Consolidated Statements of Cash Flows Years Ended December 31, 2015 2014 2013 Operating activities Net loss $(104,793,141) $(30,691,460) $(26,868,198) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 139,626 25,481 23,249 Share-based compensation expense 10,890,905 3,843,878 391,393 Issuance of stock for services 182,599 176,085 — Amortization of premiums on investment activities 712,675 297,223 — Changes in operating assets and liabilities: Accounts receivable 20,943 284,715 (35,889) Prepaid expenses and other assets (6,737,125) (466,099) (574,341) Accounts payable (419,860) (1,342,302) 3,353,459 Accrued liabilities and employee benefits (3,873,692) 5,065,329 2,785,736 Deferred revenue — — (1,666,674) Deferred rent 1,597,105 — — Net cash used in operating activities (102,279,965) (22,807,150) (22,591,265) Investing activities Purchases of investments (514,308,249) (103,601,836) — Maturities of investments 153,389,448 36,879,308 1,500,000 Purchase of property and equipment (860,595) (11,762) (33,255) Net cash (used in) provided by investing activities (361,779,396) (66,734,290) 1,466,745 Financing activities Proceeds from issuance of convertible promissory notes, net — — 100,000 Proceeds from stock option exercises 653,046 162,980 332,938 Proceeds from stock subscription — 109,833 109,834 Proceeds of public offerings 449,996,887 116,191,285 43,841,850 Payment of costs of public offerings (756,313) (748,538) (3,754,706) Net cash provided by financing activities 449,893,620 115,715,560 40,629,916 Net (decrease) increase in cash and cash equivalents (14,165,741) 26,174,120 19,505,396 Cash and cash equivalents at beginning of period 61,325,044 35,150,924 15,645,528 Cash and cash equivalents at end of period $47,159,303 $61,325,044 $35,150,924 Cash paid for interest $— $7,073 $11,320 See accompanying notes to consolidated financial statements. F-6Table of ContentsIntra-Cellular Therapies, Inc.Notes to Consolidated Financial StatementsDecember 31, 20151. OrganizationIntra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiary, ITI, Inc. (“ITI”), is a biopharmaceutical company focused on thediscovery and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders bytargeting intracellular signaling mechanisms within the central nervous system (“CNS”). The Company’s lead product candidate, ITI-007, is in Phase 3 clinicaldevelopment as a novel treatment for schizophrenia and bipolar depression.ITI was incorporated in the State of Delaware on May 22, 2001 under the name “Intra-Cellular Therapies, Inc.” and commenced operations in June 2002. ITI wasfounded to discover and develop drugs for the treatment of neurological and psychiatric disorders.On August 29, 2013, ITI completed a reverse merger (the “Merger”) with a public shell company named Oneida Resources Corp. (“Oneida”). Oneida was formedin August 2012 as a vehicle to investigate and, if such investigation warranted, acquire a target company or business seeking the perceived advantages of being apublicly held corporation. In the Merger, each outstanding share of capital stock of ITI was exchanged for 0.5 shares of common stock of Oneida, and eachoutstanding option to purchase one share of ITI common stock and each outstanding warrant to purchase one share of ITI common stock was assumed by Oneidaand became exercisable for 0.5 shares of Oneida common stock. As a result of the Merger and related transactions, ITI survived as a wholly-owned subsidiary ofOneida, Oneida changed its fiscal year end from March 31 to December 31, and Oneida changed its name to Intra-Cellular Therapies, Inc. (the “Company”). Inaddition, the Company began operating ITI and its business, and therefore ceased being a shell company. Following the Merger and the redemption of all thenoutstanding shares of Oneida at the closing of the Merger, the former stockholders of ITI owned 100% of the shares of the Company’s outstanding capital stock.In accordance with Financial Accounting Standards Board (“FASB”), Accounting Standards Codification (“ASC”) Topic 805, Business Combinations , ITI isconsidered the acquirer for accounting purposes, and has accounted for the transaction as a capital transaction, because ITI’s former stockholders received 100% ofthe voting rights in the combined entity and ITI’s senior management represented all of the senior management of the combined entity. Consequently, the assetsand liabilities and the historical operations that are reflected in the Company’s consolidated financial statements are those of ITI and have been recorded at thehistorical cost basis of the Company. All share and per share amounts in the consolidated financial statements and related notes have been retrospectively adjustedto reflect the one-for-0.5 shares of capital stock exchange as well as the conversion of the Notes (defined below) and the Series A, B, and C redeemable convertiblepreferred stock of ITI.Immediately prior to the Merger, on August 29, 2013, ITI sold to accredited investors approximately $60.0 million of its shares of common stock, or 18,889,307shares at a price of $3.1764 per share (the “Private Placement”), which included $15.3 million in principal and $0.8 million in accrued interest from the conversionof ITI’s then outstanding convertible promissory notes (the “Notes”).On February 5, 2014, the Company completed a public offering of common stock in which the Company sold 7,063,300 shares of common stock, which includedthe exercise of the underwriters’ option to purchase an additional 921,300 shares, at an offering price of $17.50 per share. After deducting underwriting discounts,commissions and offering expenses, the net proceeds to the Company were approximately $115.4 million. F-7Table of Contents1. Organization (continued) On October 31, 2014, the Company entered into a termination agreement with Takeda Pharmaceutical Company Limited (“Takeda”) terminating the worldwidelicense and collaboration agreement under which the Company and Takeda were jointly developing the Company’s proprietary compound ITI-214 and otherselected compounds that selectively inhibit phosphodiesterase type 1 (“PDE1”) for use in the prevention and treatment of human diseases. Through December 31,2015, the Company had received $29.0 million in total payments under the agreement and was eligible to receive milestone payments and royalties based on netsales. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug application (“IND”) for ITI-214 to the Company. The Companyintends to explore the development of its PDE program, including ITI-214 for the treatment of several CNS and non-CNS conditions.On March 11, 2015, the Company completed a public offering of common stock in which the Company sold 5,411,481 shares of common stock, which includedthe exercise of the underwriters’ option to purchase an additional 661,481 shares, at an offering price of $24.00 per share. After deducting underwriting discounts,commissions and offering expenses, the net proceeds to the Company were approximately $121.8 million.On September 28, 2015, the Company completed a public offering of common stock in which the Company sold 7,935,000 shares of common stock, whichincluded the exercise of the underwriters’ option to purchase an additional 1,035,000 shares, at an offering price of $43.50 per share. After deducting underwritingdiscounts, commissions and offering expenses, the net proceeds to the Company were approximately $327.4 million.In order to further its research projects and support its collaborations, the Company will require additional financing until such time, if ever, that revenue streamsare sufficient to generate consistent positive cash flow from operations. Possible sources of funds include public or private sales of the Company’s equity securities,sales of debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s product candidates andtechnology and, to a lesser extent, grant funding.2. Summary of Significant Accounting PoliciesBasis of PresentationThe accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America(“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles asfound in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).Use of EstimatesThe preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in thefinancial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences wouldbe material.Cash and Cash EquivalentsThe Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cashequivalents consist of checking accounts, money market accounts, money market mutual funds, and certificates of deposit with a maturity date of three months orless. Their carrying values approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with a maturity dateof more than three months are classified separately on the balance sheet. F-8Table of Contents2. Summary of Significant Accounting Policies (continued) Investment SecuritiesInvestment securities may consist of investments in U.S. Treasuries, various U.S. governmental agency debt securities, corporate bonds, certificates of deposit, andother fixed income securities with an average maturity of twelve months or less. Management classifies the Company’s investments as available-for-sale. Suchsecurities are carried at estimated fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated othercomprehensive income, which is a separate component of stockholders’ equity. Realized gains and losses, and declines in value judged to be other-than-temporary,if any, are included in consolidated results of operations. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interestincome is recognized as interest income when earned. The cost of securities sold is calculated using the specific identification method.Investment securities consisted of the following (in thousands): December 31, 2015 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. government agency securities $61,510 $— $(271) $61,239 FDIC certificates of deposit (1) 41,343 1 (11) 41,333 Certificates of deposit 219,500 — — 219,500 Commercial paper 30,122 — (48) 30,074 Corporate bonds/notes 76,157 — (262) 75,895 $428,632 $1 $(592) $428,041 December 31, 2014 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. government agency securities $4,316 $— $(3) $4,313 FDIC certificates of deposit (1) 16,374 — (14) 16,360 Certificates of deposit 2,000 — — 2,000 Commercial paper 9,743 1 — 9,744 Corporate bonds/notes 35,992 — (89) 35,904 $68,425 $1 $(106) $68,321 (1)“FDIC certificates of deposit” consist of deposits that are less than $250,000.The Company has classified all of its investment securities available-for-sale, including those with maturities beyond one year, as current assets on the consolidatedbalance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in currentoperations. As of December 31, 2015 and December 31, 2014, the Company held $142.4 million and $31.8 million, respectively, of available-for-sale investmentsecurities with contractual maturity dates more than one year and less than two years.The Company monitors its investment portfolio for impairment quarterly or more frequently if circumstances warrant. In the event that the carrying value of aninvestment exceeds its fair value and the decline in value is determined to be other-than-temporary, the Company records an impairment charge within earningsattributable to the estimated credit loss. In determining whether a decline in the value of an investment is other-than-temporary, the Company evaluates currentlyavailable factors that may include, among others: (1) general market conditions; (2) the duration and extent to which fair value has been less than the carrying F-9Table of Contents2. Summary of Significant Accounting Policies—(Continued) value; (3) the investment issuer’s financial condition and business outlook; and (4) our assessment as to whether it is more likely than not that we will be requiredto sell a security prior to recovery of its amortized cost basis.As of December 31, 2015 the Company had approximately $9.2 million of investments that have been held for greater than one year which had a temporaryimpairment of approximately $19,000. As of December 31, 2014 the Company had no investments that had been held for greater than one year.The Company attributes the unrealized losses on the available-for-sale securities as of December 31, 2015 and 2014, to the variability in related market interestrates. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of theircontractual terms. Furthermore, the Company does not believe that these securities expose us to undue market risk or counterparty credit risk. As such, theCompany does not consider these securities to be other-than-temporarily impaired.Fair Value MeasurementsThe Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures . ASC Topic 820 defines fair value, establishes a fairvalue hierarchy for assets and liabilities measured at fair value and requires expanded disclosures about fair value measurements. The ASC Topic 820 hierarchyranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to beclassified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement: • Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quotedprices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can alsoinclude those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant andsubjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with agiven security.The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classifythem each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair valueand where such inputs lie within the ASC Topic 820 hierarchy.The Company has no assets or liabilities that were measured using quoted prices for significant unobservable inputs (Level 3 assets and liabilities) as ofDecember 31, 2015 and December 31, 2014. The carrying value of cash held in money market funds of approximately $31.1 million as of December 31, 2015 and$8.5 million as of December 31, 2014, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. F-10Table of Contents2. Summary of Significant Accounting Policies (continued) The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at Reporting Date Using December 31, 2015 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money market funds $31,114 $31,114 $— $— U.S. government agency securities 61,239 — 61,239 — FDIC certificates of deposit 41,333 — 41,333 — Certificates of deposit 219,500 — 219,500 — Commercial paper 30,074 — 30,074 — Corporate bonds/notes 75,895 — 75,895 — $459,155 $31,114 $428,041 $— Fair Value Measurements at Reporting Date Using December 31, 2014 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money market funds $8,495 $8,495 $— $— U.S. government agency securities 4,313 — 4,313 — FDIC certificates of deposit 16,360 — 16,360 — Certificates of deposit 41,000 — 41,000 — Commercial paper 9,744 — 9,744 — Corporate bonds/notes 35,903 — 35,903 — $115,815 $8,495 $107,320 $— Financial InstrumentsThe Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, accounts payable andaccrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2015 and December 31, 2014. Management believesthat the risks associated with its financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies ofhigh credit standing.Concentration of Credit RiskCash equivalents are held with major financial institutions in the United States. Certificates of deposit, cash and cash equivalents held with banks may exceed theamount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk.Accounts ReceivableAccounts receivable that management has the intent and ability to collect are reported in the balance sheets at outstanding amounts, less an allowance for doubtfulaccounts. The Company writes off uncollectible receivables when the likelihood of collection is remote. F-11Table of Contents2. Summary of Significant Accounting Policies (continued) The Company evaluates the collectability of accounts receivable on a regular basis. The allowance, if any, is based upon various factors including the financialcondition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect futurecollections experience. No allowance was recorded as of December 31, 2015 and 2014, as the Company has a history of collecting on all its accounts includinggovernment agencies and collaborations funding its research.Property and EquipmentProperty and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leaseholdimprovements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expendituresfor maintenance and repairs are charged to operations as incurred.When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteriaestablished in ASC 360, Property, Plant and Equipment . The Company considers historical performance and anticipated future results in its evaluation of potentialimpairment. The Company evaluates the carrying value of those assets in relation to the operating performance of the business and undiscounted cash flowsexpected to result from the use of those assets. Impairment losses are recognized when carrying value exceeds the undiscounted cash flows, in which casemanagement must determine the fair value of the underlying asset. No such impairment losses have been recognized to date.Revenue RecognitionRevenue is recognized when all terms and conditions of the agreements have been met, including persuasive evidence of an arrangement, delivery has occurred orservices have been rendered, price is fixed or determinable and collectability is reasonably assured. The Company is reimbursed for certain costs incurred onspecified research projects under the terms and conditions of grants, collaboration agreements, and awards. The Company records the amount of reimbursement asrevenues on a gross basis in accordance with ASC Topic 605-45, Revenue Recognition/Principal Agent Considerations . The Company is the primary obligor withrespect to purchasing goods and services from third-party suppliers, is obligated to compensate the service provider for the work performed, and has discretion inselecting the supplier. Provisions for estimated losses on research grant projects and any other contracts are made in the period such losses are determined.The Company has entered into arrangements involving the delivery of more than one element. Each required deliverable is evaluated to determine whether itqualifies as a separate unit of accounting. For the Company, this determination is generally based on whether the deliverable has “stand-alone value” to thecustomer. The Company adopted this accounting standard on a prospective basis for all Multiple-Deliverable Revenue Arrangements (“MDRAs”) entered into onor after January 1, 2011, and for any MDRAs that were entered into prior to January 1, 2011, but materially modified on or after that date.The Company has adopted ASC Topic 605-28, Milestone Method . Under this guidance, the Company recognizes revenue contingent upon the achievement of asubstantive milestone in its entirety in the period the milestone is achieved. Substantive milestone payments are recognized upon achievement of the milestone onlyif all of the following conditions are met: • The milestone payments are non-refundable; • Achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • Substantive effort on the Company’s part is involved in achieving the milestone; • The amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and F-12Table of Contents2. Summary of Significant Accounting Policies (continued) • A reasonable amount of time passes between the up-front license payment and the first milestone payment, as well as between each subsequentmilestone payment.Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resultingpayment would not be considered a substantive milestone, and therefore, the resulting payment would be considered part of the consideration for the single unit ofaccounting and be recognized as revenue in accordance with the revenue models described above. In addition, the determination that one such payment was not asubstantive milestone could prevent the Company from concluding that subsequent milestone payments were substantive milestones and, as a result, any additionalmilestone payments could also be considered part of the consideration for the single unit of accounting and would be recognized as revenue as such performanceobligations are performed under either the proportional performance or straight-line methods, as applicable .Research and DevelopmentExcept for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, theCompany recognizes research and development expense as the services are rendered. Research and development costs primarily consist of salaries and relatedexpenses for personnel and resources and the costs of clinical trials. Other research and development expenses include preclinical analytical testing, outsideservices, providers, materials and consulting fees.Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data suchas subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for theseactivities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements asprepaid or accrued research and development expense, as the case may be.As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts withvendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of thesecontracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials orservices are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching thoseexpenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trialas measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking intoaccount discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. Duringthe course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of itsaccrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependentupon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to bematerially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing ofservices performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2015and 2014, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials.Income TaxesIncome taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable todifferences between the financial statement carrying amounts of F-13Table of Contents2. Summary of Significant Accounting Policies (continued) existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxableincome in the year in which those temporary differences are expected to be recovered or settled.The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowancesare established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and thechange during the period in deferred tax assets and liabilities.The Company accounts for uncertain tax positions pursuant to ASC Topic 740 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty inIncome Taxes—an Interpretation of FASB Statement No. 109 ). Financial statement recognition of a tax position taken or expected to be taken in a tax return isdetermined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized ismeasured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interestaccrued related to unrecognized tax benefits and penalties in the provision for income taxes.Comprehensive Income (Loss)All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred.Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances fromnon-owner sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or (losses) on its investment securities in aseparate statement of comprehensive income (loss) for each period.Share-Based CompensationShare-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation . The fair value of share-basedpayments is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model (the “Black-Scholes model”). The resulting fair value isrecognized ratably over the requisite service period, which is generally the vesting period of the option.For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. For awards that contain a performance-based vesting condition, expense is amortized using the accelerated attribution method. Share-based compensation expense recognized in the statements ofoperations for the years ended December 31, 2015, 2014 and 2013 is based on share-based awards ultimately expected to vest, and this amount has therefore beenreduced for estimated forfeitures. ASC Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actualforfeitures differ from those estimates. Pre-vesting forfeitures were estimated based on the Company’s historical experience and have not been material.The Company utilizes the Black-Scholes model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes model,require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptionsinclude the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Restricted stock units are valued at the fairmarket value on the date of grant as determined by the closing stock price.Expected volatility rates are based on historical volatility of the common stock of comparable publicly traded entities and other factors due to the limited historicalinformation about the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to beoutstanding. F-14Table of Contents2. Summary of Significant Accounting Policies (continued) Given the limited historical exercise data, the expected life is determined using the “simplified method,” which is defined as the midpoint between the vesting dateand the end of the contractual term.The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. TheCompany has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Companyhas assumed an expected dividend rate of zero.Prior to January 1, 2014, given that there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant wasdetermined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development andperformance, the price per share of its convertible preferred stock offerings and general industry and economic trends. In establishing the estimated fair value of thecommon stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation . For stock options granted in 2014 and 2015, the exercise price was determined by using the closing marketprice of the Company’s common stock on the date of grant.Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future taxdeduction under existing tax law shall be considered to be a deductible temporary difference in applying ASC Topic 740, Income Taxes . The deductible temporarydifference is based on the compensation cost recognized for financial reporting purposes; however, these provisions currently do not impact the Company, as all thedeferred tax assets have a full valuation allowance.Since the Company had net operating loss carryforwards as of December 31, 2015, 2014 and 2013, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations.Equity instruments issued to consultants are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees . Accordingly, the estimated fair value of the equity instrument is recorded on the earlier of the performance commitment date or the date the servicesrequired are completed and are marked to market during the service period.Loss Per ShareBasic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, withoutconsideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stockequivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants.The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the lossfrom operations for the years ended December 31, 2015, 2014 and 2013: Years Ended December 31, 2015 2014 2013 Stock Equivalents 1,322,311 958,712 898,982 Recently Issued Accounting StandardsIn November 2015, the FASB issued Accounting Standards Update No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes.Current GAAP requires an entity to separate deferred income tax liabilities and assets into current and noncurrent amounts in a classified statement of financialposition. To simplify the presentation of deferred income taxes, ASU 2015-17 requires that deferred tax F-15Table of Contents2. Summary of Significant Accounting Policies (continued) liabilities and assets be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax liabilities and assets of atax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this Update. The amendments in this Update areeffective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Earlier applicationis permitted for all entities as of the beginning of an interim or annual reporting period. The Company has elected to adopt this update as of the fourth quarter of2015, retrospectively. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements and accompanying notes.In May 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminatetransaction-specific and industry-specific revenue recognition guidance under current GAAP and replace it with a principle-based approach for determiningrevenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract.ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts,including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB decidedto defer the effective date of the standard from January 1, 2017, to January 1, 2018, with an option that permits companies to adopt the standard as early as theoriginal effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulativeeffect transition method. Presently, the Company is assessing what effect the adoption of this standard will have on our consolidated financial statements andaccompanying notes.3. Property and EquipmentProperty and equipment consist of the following: December 31, 2015 2014 Computer equipment $42,064 $39,160 Furniture and fixtures 266,695 35,958 Scientific equipment 2,823,601 2,207,848 3,132,360 2,282,966 Less accumulated depreciation (2,356,838) (2,228,413) $775,522 $54,553 Depreciation expense for the years ended December 31, 2015, 2014 and 2013 was $139,626, $25,481 and $23,249, respectively. During 2015, the Company retired$11,201 of fully depreciated property and equipment. During 2014, in conjunction with its move in February 2015 to its new headquarters, the Company retired$319,553 of fully depreciated leasehold improvements and disposed of $709,518 of fully depreciated property and equipment.4. Share-Based CompensationThe Company sponsors the Intra-Cellular Therapies, Inc. 2013 Equity Incentive Plan (the “2013 Plan”) to provide for the granting of stock-based awards, such asstock options, restricted common stock, restricted stock units and stock appreciation rights to employees, directors and consultants as determined by the Board ofDirectors. In August 2013, the Company assumed in the Merger the ITI 2003 Equity Incentive Plan, as amended (the “2003 Plan”), which expired by its terms inJuly 2013. As of December 31, 2015, there were options to F-16Table of Contents4. Share-Based Compensation (continued) purchase 2,737,657 shares of common stock outstanding under the 2013 Plan. Effective in November 2013, the Company adopted the 2013 Plan. The Companyinitially reserved 2,850,000 shares of common stock for issuance under the 2013 Plan. In both January 2015 and 2014, the number of shares of common stockreserved for issuance under the 2013 Plan automatically increased by 800,000 pursuant to the evergreen provisions of the 2013 Plan. On June 16, 2015, thestockholders of the Company approved, at the Company’s 2015 Annual Meeting of Stockholders, an amendment to the 2013 Plan to increase the number of sharesof common stock available for issuance under the plan by 3,100,000 shares, to increase by 100,000 shares the maximum number of shares available for the issuanceof options, stock appreciation rights and other similar awards to any one participant in any calendar year for purposes of meeting the requirements for qualifiedperformance-based compensation under Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Code”), and to eliminate the evergreen provisionsof the 2013 Plan under which 800,000 shares were automatically added to the plan on each of January 1, 2014 and 2015.Stock options granted under the 2013 Plan may be either incentive stock options (“ISOs”) as defined by the Code, or non-qualified stock options. The Board ofDirectors determines who will receive options, the vesting periods (which are generally two to three years) and the exercise prices of such options. Options have amaximum term of 10 years. The exercise price of ISOs granted under the 2013 Plan must be at least equal to the fair market value of the common stock on the dateof grant.Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and restricted stock units to employees,directors and consultants recognized during the years ended December 31, 2015, 2014 and 2013, was comprised of the following: Years Ended December 31, 2015 2014 2013 Research and development $4,768,131 $1,842,828 $132,543 General and administrative 6,122,774 2,001,050 258,850 Total share-based compensation expense $10,890,905 $3,843,878 $391,393 The following table describes the weighted-average assumptions used for calculating the value of options granted during the years ended December 31, 2015, 2014and 2013: 2015 2014 2013 Dividend yield 0% 0% 0% Expected volatility 80.0% 80.0% 80.0% Weighted-average risk-free interest rate 1.8% 2.0% 2.2% Expected term (in years) 5.9 6.3 6.2 Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2015, and changesduring the period then ended, are summarized as follows: Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Weighted- Average ContractualLife Outstanding at December 31, 2014 2,233,460 $9.20 $— 7.3 years Options granted 884,703 $21.00 $— 9.1 years Options exercised (305,005) $2.14 $— 2.2 years Options canceled or expired (75,501) $12.33 $— 8.0 years Outstanding at December 31, 2015 2,737,657 $13.72 $109,778,658 7.6 years Vested or expected to vest at December 31, 2015 2,737,657 $13.72 $— Exercisable at December 31, 2015 1,485,918 $8.75 $66,920,372 6.7 years F-17Table of Contents4. Share-Based Compensation (continued) The weighted-average grant date fair value for awards granted during the years ended December 31, 2015, 2014, and 2013, was $21.00, $16.50, and $3.26 pershare, respectively. Total intrinsic value of the options exercised during the years ended December 31, 2015, 2014, and 2013 was approximately $10,951,057,$3,696,775 and $580,623, respectively. The total fair value of shares vested in the years ended December 31, 2015, 2014 and 2013, was approximately $5,207,073,$3,703,000 and $278,000, respectively.During 2015, 2014 and 2013, the Company granted options to certain scientific advisory board members of the Company to purchase 45,571, 95,000 and 19,000shares of common stock at an average exercise price per share of $17.57, $16.86, and $3.26, respectively. The options vest ratably over a period of 12 to 24 months.Stock compensation related to these grants will fluctuate with any changes in the underlying value of the Company’s common stock, as the performance period isnot fixed.The unrecognized share-based compensation expense related to stock option awards at December 31, 2015, is $12,733,859 and will be recognized over a weighted-average period of 1.6 years.5. Income TaxesTotal income tax expense for the years ended December 31 is allocated as follows: December 31, 2015 2014 2013 Current $1,600 $1,600 $18,000 Deferred (51,165,859) (14,655,320) (13,229,355) Valuation allowance 51,165,859 14,655,320 13,229,355 Provision for income taxes $1,600 $1,600 $18,000 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31 is as follows: December 31, 2015 2014 2013 Income tax benefit at statutory federal rate 35.00% 35.00% 35.00% Permanent differences (0.56) 0.12 (1.20) Return-to-provision—R&D Credit 0.00 (0.05) 2.61 R&D Credit—current year 4.19 2.32 3.72 Reserve for uncertain tax positions 0.00 (0.01) (6.53) Change in effective state tax rates (0.05) (0.14) 6.58 State income tax expense 10.24 10.50 10.12 Change in valuation allowance (48.82) (47.75) (50.37) Provision for income taxes (0.00)% (0.01)% (0.07)% Deferred income taxes reflect the net tax effect of temporary differences that exist between the carrying amounts of assets and liabilities for financial reportingpurposes and the amounts used for income tax purposes, using enacted tax rates in effect for the year in which the differences are expected to reverse. As ofDecember 31, 2015, the Company had $174.8 million of federal net operating loss carryforwards, which expire at various dates through 2035. The gross amount ofthe state net operating loss carryforwards is equal to or less than the federal net operating loss carryforwards and expires over various periods based on individualstate tax law. In general, businesses with U.S. net operating losses (“NOLs”) are considered loss corporations for U.S. federal income tax purposes. Pursuant toSection 382 of the Code, loss corporations that undergo an ownership change, as defined under the Code, may be subject to an annual limitation on the amount ofNOLs (and certain other tax attributes) F-18Table of Contents5. Income Taxes (continued) available to offset taxable income earned after such ownership change. For the year ended December 31, 2015, the Company performed a Section 382 ownershipanalysis and determined that an ownership change occurred (within the meaning of Section 382 of the Code) in 2015. Based on the analysis performed, however,the Company does not believe that the Section 382 annual limitation will impact the Company’s ability to utilize the tax attributes that existed as of the date of theownership change in a material manner. If the Company experiences an ownership change in the future, the tax benefits related to the NOLs and tax creditcarryforwards may be further limited or lost.At December 31, 2015, the Company had $5.7 million in excess tax benefits related to stock-based compensation deductions, the benefit of which will be recordedto additional paid-in-capital once the benefit is realized through a reduction of income taxes payable. The following summarizes the significant components of theCompany’s deferred tax assets and liabilities as of December 31, 2015 and 2014, respectively: December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $76,741,198 $34,870,169 Accrued employee benefits 543,466 443,371 Research and development credit 6,962,731 2,570,540 Stock compensation 5,641,993 1,563,785 Deferred rent 725,195 — Deferred tax liabilities: Depreciation (6,062) (5,204) Net deferred tax asset 90,608,521 39,442,661 Valuation allowance (90,608,521) (39,442,661) Net deferred tax asset $— $— Based upon the Company’s historical operating performance and the reported cumulative net losses to date, the Company presently does not have sufficientobjective evidence to support the recovery of its net deferred tax assets. Accordingly, the Company has established a valuation allowance against its net deferredtax assets for financial reporting purposes because it is not more likely than not that these deferred tax assets will be realized.The total amount of unrecognized tax benefits as of December 31, 2015 and December 31, 2014 were $1.72 million and $1.72 million respectively. If recognizednone of these tax benefits would affect the effective tax rate due to valuation allowances.The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2015 and 2014, respectively: December 31, 2015 2014 Balance at January1, $1,717,635 $1,715,904 Current Year Uncertain Tax Positions: Gross Increases 3,277 1,731 Prior Year Uncertain Tax Positions: Balance at December 31, $1,720,912 $1,717,635 F-19Table of Contents6. Collaborations and License AgreementsThe Bristol-Myers Squibb License AgreementOn May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), pursuant to which theCompany holds a license to certain patents and know-how of BMS relating to ITI-007 and other specified compounds. The agreement was amended onNovember 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome andcardiovascular disease. However, BMS has no right to use, develop or commercialize ITI-007 and other specified compounds in any field of use. The Company hasthe right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the license to use commercially reasonable efforts to develop andcommercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitivecompounds.Under the agreement, the Company made an upfront payment of $1.0 million to BMS, a milestone payment of $1.25 million in December 2013, and a milestonepayment of $1.5 million in December 2014 following the initiation of the Company’s first Phase 3 clinical trial for ITI-007 for patients with exacerbatedschizophrenia. Possible milestone payments remaining total $12.0 million. Under the agreement, the Company may be obliged to make other milestone paymentsto BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentageroyalty payments on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty payments made in consideration of anysublicense.The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of ten years after first commercial saleof a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration of othergovernment grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. Ontermination of the agreement, the Company may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product,including regulatory filings, research results and other intellectual property rights.The Takeda Pharmaceutical License and Collaboration Agreement and Termination AgreementOn February 25, 2011, the Company entered into a license and collaboration agreement with Takeda Pharmaceutical Company Limited under which the Companyagreed to collaborate to research, develop and commercialize its proprietary compound ITI-214 and other selected compounds that selectively inhibit PDE1 for usein the prevention and treatment of human diseases. As part of the agreement, the Company assigned to Takeda certain patents owned by the Company that claimITI-214 and granted Takeda an exclusive license to develop and commercialize compounds identified in the conduct of the research program that satisfy specifiedcriteria. However, the Company retained rights to all compounds that do not meet the specified criteria and the Company continues to develop PDE1 inhibitorsoutside the scope of the agreement.Under the terms of the agreement, the Company conducted a research program with an initial term of three years to identify and characterize compounds that meetcertain specified criteria sufficient for further development by Takeda. This research program ended in February 2014. The Company was responsible for itsexpenses incurred in the conduct of certain research activities specified in the research plan. Takeda agreed to reimburse the Company for expenses the Companyincurred in conducting additional research activities.Upon execution of the agreement, Takeda made a nonrefundable payment to the Company. The Company was eligible to receive payments of approximately $500million in the aggregate upon achievement of certain development milestones and up to an additional $250 million in the aggregate upon achievement of certainsales-based milestones, along with tiered royalty payments ranging from the high single digits to the low teens in percent based on net sales by Takeda. F-20Table of Contents6. Collaborations and License Agreements (continued) On October 31, 2014, the Company entered into an agreement with Takeda terminating the Takeda License Agreement, pursuant to which all rights granted underthe Takeda License Agreement were returned to the Company. On September 15, 2015, Takeda completed the transfer of the IND for ITI-214 to the Company. ITI-214 is the first compound in its class to successfully advance into Phase 1 clinical trials. The Company intends to explore the development of its PDE program,including ITI-214 for the treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease,cognition in schizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also being advanced for the treatment of variousindications.Other License AgreementIn May 2002, ITI entered into a license agreement (the “License”) and research agreement with a university. Under the provisions of the License, ITI is entitled touse this organization’s patented technology and other intellectual property relating to diagnosis and treatment of central nervous system disorders.The License expires upon expiration of the patent rights or 15 years subsequent to the first sale of products developed through this License. ITI is required to makefuture milestone payments for initiation of clinical trials and approval of a New Drug Application (“NDA”). Should ITI commercialize the technology related tothis License, ITI would be required to make royalty payments, and would also be required to pay fees under any sublicense agreements with third parties.In addition, ITI is required to use at least $1.0 million annually of its resources for the development and commercialization of the technology until ITI submits anNDA. ITI met its spending requirements in 2015. There were no other payments made or required under the License for the years ended December 31, 2015 and2014.7. Commitments and ContingenciesThe Company currently has operating lease agreements with commitments for $16,255,927 for laboratory and office facilities through 2027.At December 31, 2015, future minimum lease payments under leases having an initial or remaining non-cancellable lease term in excess of one year are set forth inthe table below: Year 2016 $0 2017 1,299,845 2018 1,457,008 2019 1,500,718 2020 1,545,740 Thereafter 10,452,616 $16,255,927 Rent expense for the years ended December 31, 2015, 2014 and 2013 was $1,385,207, $853,504 and $827,479, respectively.8. Employee Benefit PlanThe Company sponsors a defined contribution 401(k) plan covering all full-time employees. Participants may elect to contribute their annual pre-tax earnings up tothe federally allowed maximum limits. The Company makes a matching contribution of 50% on the first 6% of contributions made by participants. Participant andCompany contributions vest immediately. During the years ended December 31, 2015, 2014 and 2013, the Company recorded matching contribution expense of$109,963, $84,757 and $77,138, respectively. F-21Table of Contents9. Related PartiesIn the first quarter of 2015, the Company moved its headquarters to 430 East 29th Street, New York, New York 10016. The Company has entered into a long-termlease for approximately 16,753 square feet of useable laboratory and office space . The lease has a term of 12 years. Due to the amortization of total leasepayments, the Company has recognized $1.6 million of deferred rent in the 12 months ended December 31, 2015. The deferred rent balance will incrementallyincrease over the next two years. A member of the Company’s board of directors is the Chairman of the board of directors, Chief Executive Officer and Presidentof the parent company to the landlord under this lease.10. Unaudited Quarterly Financial InformationThe tables herein set forth the Company’s unaudited condensed consolidated 2015 and 2014 quarterly statements of operations.The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2015 quarters ended: 2015 Quarter Ended December 31, September 30, June 30, March 31, Revenue $30,659 $— $57,390 $3,315 Net loss (28,834,516) (32,160,483) (21,511,318) (22,286,824) Basic and diluted net loss per share $(0.67) $(0.91) $(0.61) $(0.72) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2014 quarters ended: 2014 Quarter Ended December 31, September 30, June 30, March 31, Revenue $65,862 $124,414 $219,238 $167,787 Net loss (15,199,130) (6,415,507) (4,533,539) (4,543,284) Basic and diluted net loss per share $(0.52) $(0.22) $(0.15) $(0.17) F-22Exhibit 10.6EMPLOYMENT AGREEMENTTHIS EMPLOYMENT AGREEMENT (the “Agreement”), is effective this 4th day of November, 2015 (the “Effective Date”) between Robert Davis(“Executive”) and Intra-Cellular Therapies, Inc. (the “Company”).1. Title; Capacity . Subject to terms set forth herein, the Company agrees to employ Executive in the position of Senior Vice President, Chief ScientificOfficer. Executive shall serve in an executive capacity and shall perform such duties as are assigned to Executive from time to time, consistent with the Bylaws ofthe Company and as required by the Company’s Board of Directors (the “Board”). During the term of his employment with the Company, Executive will devote hisbest efforts and substantially all of his business time and attention to the business of the Company. Notwithstanding the foregoing, or any other provision of thisAgreement, it shall not be a breach or violation of this Agreement for the Executive to (i) serve on civic or charitable boards or committees, (ii) with the expresswritten permission of the Company serve on corporate boards of companies that do not present a conflict of interest or compete directly or indirectly with theCompany, (iii) deliver lectures, fulfill speaking engagements or teach at educational institutions, or (iv) manage personal investments, so long as such activities donot significantly interfere with or significantly detract from the performance of the Executive’s responsibilities to the Company in accordance with this Agreement.The Board has approved the Executive’s participation in the activities listed on Schedule A to this Agreement.2. Term . The term of this Agreement shall commence on the Effective Date, and shall continue for three (3) years from that date, unless terminated priorthereto by either the Company or the Executive as provided in Section 4. If either the Company or the Executive does not wish to renew this Agreement when itexpires at the end of the initial or any renewal term hereof, as hereinafter provided, or if either the Company or the Executive wishes to renew this Agreement ondifferent terms than those contained herein, it or he shall give written notice in accordance with Section 13 below of such intent to the other party at least sixty(60) days prior to the expiration date. In the absence of such notice, this Agreement shall be renewed on the same terms and conditions contained herein for a termof one year from the date of expiration. The parties expressly agree that designation of a term and renewal provisions in this Agreement does not in any way limitthe right of the parties to terminate this Agreement at any time as hereinafter provided. Reference herein to the term of this Agreement shall refer both to the initialterm and any successive term as the context requires. Should the Company elect not to renew this Agreement for reasons other than death or Disability (as definedin Section 4.3 below), or Cause (as defined in Section 4.1 below), the Executive shall be eligible for the same severance payments and benefits as Executive wouldreceive under Section 5.2 and on the same conditions as if Executive had been terminated by the Company without Cause, provided that Executive executes aRelease of claims in favor of the Company as defined in Section 5.2(a). Provided however , Executive shall not receive any such severance payments and benefitsunless he executes the Release within the consideration period specified therein and until the Release becomes effective and can no longer be revoked by Executiveunder its terms. Executive’s ability to receive such payment and benefits is further conditioned upon his: returning all Company property; complying with his posttermination obligations under this Agreement and 1the Proprietary Information, Inventions, and Non-Competition Agreement between the Executive and the Company; and complying with the Release includingwithout limitation any non-disparagement and confidentiality provisions contained therein. Executive shall not be eligible for any severance payments and benefitsif either the Executive or the Company wishes to renew this Agreement on different terms than those contained herein.3. Compensation and Benefits .3.1 Salary . Executive will receive for Executive’s services to be rendered under this Agreement an initial annualized base salary at the rate of$400,000 per year, subject to annual review and adjustment by the Company in the discretion of the Board, payable subject to standard federal and state payrollwithholding requirements in accordance with the Company’s standard payroll practices (“ Base Salary ”).3.2 Incentive Compensation . In addition to Executive’s Base Salary, the Executive shall be eligible during the term of this Agreement for such bonuspayments and/or equity grants as awarded to the Executive by the Board.3.3 Policies and Fringe Benefits . The employment relationship between the parties shall also be subject to the Company’s personnel policies andprocedures as they may be interpreted, adopted, revised or deleted from time to time in the Company’s sole discretion. The Executive will be eligible to participateon the same basis as other executive level employees in the Company’s benefit plans in effect from time to time during his employment. All matters of eligibilityfor coverage or benefits under any benefit plan shall be determined in accordance with the provisions of such plan. The Company reserves the right to change, alter,or terminate any benefit plan in its sole discretion. While this Agreement is in effect, the Company will provide the Executive with life insurance, for which theExecutive may designate the beneficiary or beneficiaries in an amount of $150,000, and long-term disability insurance.3.4 Reimbursement of Certain Expenses . The Company will reimburse Executive for reasonable business expenses in accordance with the Company’sexpense reimbursement policies.4. Termination of Employment . Either Executive or the Company may terminate the employment relationship at any time, for any reason, in accordancewith this Section 4.4.1 Termination for Cause . At the election of the Company, the employment relationship may be terminated for Cause upon written notice by theCompany to Executive specifying the provision or provisions of this Section 4.1 upon which the decision to terminate is based. For the purposes of this Section 4.1,“Cause” for termination shall be deemed to exist upon the occurrence of any of the following:(a) a good faith finding by the Company that Executive has engaged in gross negligence or gross misconduct that is materially injurious to theCompany;(b) Executive’s conviction of a felony or crime involving fraud or embezzlement of Company property; 2(c) Executive’s material breach of this Agreement which, if curable, has not been cured by Executive within 60 days after he shall have receivedwritten notice from the Company stating with reasonable specificity the nature of such breach;(d) material breach of fiduciary duty; or(e) refusal to follow or implement a clear and reasonable directive of the Board as a whole, or an officer of the Company, provided that such directiveis ethical and legal and which, if curable, has not been cured by Executive within 60 days after he shall have received written notice from the Company stating withreasonable specificity the nature of such refusal.4.2 Termination by the Company Without Cause or by the Executive for Good Reason . At the election of the Company it may terminate Executive’semployment for reasons other than Cause, death or Disability, at any time upon written notice by the Company to Executive. The Executive may resign fromExecutive’s employment for “Good Reason” within sixty (60) days after the occurrence of one of the events specified below, by giving prior written notice,provided that Executive has not consented in writing to one of the specified events or been notified previously of the Company’s intention to terminate Executive’semployment. As used in this Agreement Good Reason shall mean:(a) The assignment to Executive of any duties or responsibilities which result in the material diminution of Executive’s position;(b) a 5% or greater reduction by the Company in Executive’s annual Base Salary;(c) a material change in the geographic location at which the Executive is required to perform services; or(d) material breach by the Company of any material provision of this Agreement ; provided however , that any actions taken by the Company toaccommodate a disability of the Executive or pursuant to the Family and Medical Leave Act shall not be a Good Reason for purposes of this Agreement.Notwithstanding the occurrence of any of the events enumerated in Section 4.2 (a) through (d), such occurrence shall not be deemed to constitute Good Reason if,within 30 days after the giving by Executive of notice of the occurrence or existence of an event or circumstance specified above, such event or circumstance hasbeen fully corrected (provided that such right of correction by the Company shall only apply to the first such notice given by Executive). In the absence of suchcorrection, Executive’s resignation shall be effective thirty (30) days following the Executive’s notice.4.3 Death or Disability . The Executive’s employment will terminate upon the death or determination of disability of Executive. As used in thisAgreement, the determination of “disability” shall occur when the Executive is unable due to a physical or mental condition to perform the essential functions ofhis position with or without reasonable accommodation for 90 consecutive days, or 180 days in the aggregate whether or not consecutive, during any 360-dayperiod, or based on the written certification by a licensed physician of the likely continuation of such condition for such period. A determination of disability shallbe made by a physician satisfactory to both Executive and the Company, provided that if Executive and the Company do 3not agree on a physician, Executive and the Company shall each select a physician and these two together shall select a third physician, whose determination as todisability shall be binding on all parties. This definition shall be interpreted and applied consistent with the Americans with Disabilities Act, the Family andMedical Leave Act, and other applicable law.4.4 Termination by Executive without Good Reason . At the election of Executive, he may terminate employment upon not less than 30 days priorwritten notice by Executive to the Company.5. Effect of Termination .5.1 General; Termination for Cause or by the Executive Without Good Reason . In the event that Executive’s employment is terminated for anyreason, the Company shall pay to Executive the compensation and benefits, including payment for accrued but untaken vacation days, payable to Executive throughthe last day of Executive’s actual employment by the Company. If the termination is by the Company for Cause pursuant to Section 4.1 or at the election ofExecutive pursuant to Section 4.4, the Company shall have no further obligations under this Agreement.5.2 Termination by the Company Without Cause or by the Executive for Good Reason .(a) Employee shall not receive any of the benefits pursuant to this Section 5.2 unless he executes a general release in favor of the Company, in a formacceptable to the Company and substantially similar to the form attached hereto as Schedule B ( the “Release”) within the consideration period specified therein(the “Release Review Period”) and until the Release becomes effective and can no longer be revoked by Employee under its terms. Employee’s ability to receivebenefits pursuant to this Section 5.2 is further conditioned upon his: returning all Company property; complying with his post termination obligations under thisAgreement and the Proprietary Information, Inventions and Non-Competition Agreement; and complying with the Release including without limitation any non-disparagement and confidentiality provisions contained therein.(b) In the event that Executive’s employment is terminated pursuant to Section 4.2 by the Company without Cause or by the Executive for GoodReason, the Company shall pay to Executive as severance twelve months of his annual Base Salary then in effect, together with an additional amount calculated bydividing by 365 the number of days employed in the year of termination and multiplying that number by the amount of the Executive’s previous year’s bonus (ifany), such amount to be paid in one lump sum on the date the Release becomes effective, subject to standard payroll deductions and withholdings, provided,however, that if the Release Review Period begins in one tax year and ends in a later tax year, the payments under this Section 5.2(b) will be made following thedate that the Release is effective that occurs in the later tax year . Additionally, if Executive timely elects and remains eligible for continued coverage underCOBRA, the Company, as part of this Agreement, will pay that portion of Executive’s COBRA premiums it was paying prior to the Separation Date for twelve(12) months. 4(c) In the event Executive’s employment is terminated pursuant to Section 4.2, and not for Cause, death or Disability, all unvested equity awards shallbecome fully vested, all unvested stock options shall become fully vested and exercisable and any ISO’s issued to Executive will automatically convert to a non-qualified options on the 91 st day following termination, provided it has not been exercised, subject to the terms of the applicable stock plan and option agreement.(d) Termination for Death or Disability . In the event that Executive’s employment is terminated by death or because of Disability pursuant toSection 4.3, in addition to the payment of accrued salary and unused vacation provided in Section 5.1, the Company shall pay to Executive’s estate or to Executive,as the case may be, compensation which would otherwise be payable to Executive through the end of the month in which such termination occurs, and payment forany accrued but untaken vacation days.5.3 Code Sections 409A and 280G .(a) In the event that the payments or benefits set forth in Section 5.2 of this Agreement constitute “non-qualified deferred compensation” subject toSection 409A of the Internal Revenue Code of 1986, as amended (the “Code”), then the following conditions apply to such payments or benefits:(i) Any termination of Executive’s employment triggering payment of benefits under Section 5 must constitute a “separation from service”under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) before distribution of such benefits can commence. To the extent that thetermination of Executive’s employment does not constitute a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg.§1.409A-1(h) (as the result of further services that are reasonably anticipated to be provided by Executive to Company at the time Executive’semployment terminates), any such payments under Section 5 that constitute deferred compensation under Section 409A of the Code shall be delayeduntil after the date of a subsequent event constituting a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h). For purposes of clarification, this Section 5.3(a) shall not cause any forfeiture of benefits on Executive’s part, but shall only act as a delay untilsuch time as a “separation from service” occurs.(ii) Notwithstanding any other provision with respect to the timing of payments under Section 5.2 if, at the time of Executive’s termination, Executiveis deemed to be a “specified employee” of Company (within the meaning of Section 409A(a)(2)(B)(i) of the Code), then limited only to the extentnecessary to comply with the requirements of Section 409A of the Code, any payments to which Executive may become entitled under Section 5which are subject to Section 409A of the Code (and not otherwise exempt from its application) shall be withheld until the first (1 st ) business day ofthe seventh (7 th ) month following the termination of Executive’s employment, at which time Executive shall be paid an aggregate amount equal tothe accumulated, but unpaid, payments otherwise due to Executive under the terms of Section 5. 5(b) It is intended that each installment of the payments and benefits provided under Section 5 of this Agreement shall be treated as a separate“payment” for purposes of Section 409A of the Code. Neither Company nor Executive shall have the right to accelerate or defer the delivery of any such paymentsor benefits except to the extent specifically permitted or required by Section 409A of the Code.(c) Notwithstanding any other provision of this Agreement to the contrary, this Agreement shall be interpreted and at all times administered in amanner that avoids the inclusion of compensation in income under Section 409A of the Code, or the payment of increased taxes, excise taxes or other penaltiesunder Section 409A of the Code. The parties intend this Agreement to be in compliance with Section 409A of the Code. Executive acknowledges and agrees thatCompany does not guarantee the tax treatment or tax consequences associated with any payment or benefit arising under this Agreement, including but not limitedto consequences related to Section 409A of the Code.(d) If any payment or benefit Executive would receive under Section 5.4 of this Agreement, when combined with any other payment or benefitExecutive receives pursuant to a Change of Control (for purposes of this section, a “Payment”) would: (i) constitute a “parachute payment” within the meaning ofSection 280G the Code; and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then such Payment shallbe either: (A) the full amount of such Payment; or (B) such lesser amount (with cash payments being reduced before equity compensation) as would result in noportion of the Payment being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and localemployments taxes, income taxes, and the Excise Tax, results in Executive’s receipt, on an after-tax basis, of the greater amount of the Payment notwithstandingthat all or some portion of the Payment may be subject to the Excise Tax.5.4 Effect of a Change in Control .(a) In the event either (i) Executive’s employment with the Company is terminated by the Company for reasons other than death or Disability (asdefined above) within three months before or 12 months following a Change in Control (as defined below) or (ii) Executive terminates his employment for GoodReason (as defined above) within three months before or 12 months following a Change in Control (as defined below), or (iii) the Executive terminates hisemployment for any reason within one (1) month following a Change in Control (as defined below), then provided that Executive executes the Release (as definedin Section 5.2) within the consideration period specified therein and it becomes effective and can no longer be revoked by Executive under its terms, and providedfurther that Executive returns all Company property’ complies with his post termination obligations under this Agreement and the Proprietary Information,Inventions and Non-Competition Agreement, and complies with the Release including without limitation any non-disparagement and confidentiality provisionscontained therein, Executive shall be entitled to the payments, equity acceleration and benefits described in this Section 5.4 in lieu of, and not in addition to, thebenefits provided for in Section 5.2. The Company shall pay to the Executive, in lieu of the severance described in Section 5.2(a), severance equivalent to 18months of his annual Base Salary then in effect, together with an additional amount calculated by dividing by 365 the number of days employed in the year oftermination and multiplying that number by the amount of the Executive’s previous year’s bonus 6(if any), paid in a lump sum on the eighth day following the date the Release becomes effective, subject to standard payroll deductions and withholdings, provided,however, that if the Release Review Period begins in one tax year and ends in a later tax year, the payments under this Section 5.4(a) will be made following thedate that the Release is effective that occurs in the later tax year. On the date of termination of Executive’s employment, any unvested equity awards granted to theExecutive shall immediately vest and, in the case of stock options, become exercisable. Additionally, if Executive timely elects and remains eligible for continuedcoverage under COBRA, the Company, as part of this Agreement, will pay that portion of Executive’s COBRA premiums it was paying prior to the SeparationDate for eighteen (18) months.(b) Definition of Change in Control . For purposes of this Agreement, a “Change in Control” means the occurrence of any of the following events:(i) a sale, lease or other disposition of all or substantially all of the assets of the Company;(ii) a consolidation or merger of the Company with or into any other corporation or other entity or person, or any other corporate reorganization,in which the stockholders of the Company immediately prior to such consolidation, merger or reorganization, own less than fifty percent (50%) of theoutstanding voting power of the surviving entity (and its parent) following the consolidation, merger or reorganization; or(iii) any transaction (or series of related transactions involving a person or entity, or a group of affiliated persons or entities) in which in excessof fifty percent (50%) of the Company’s outstanding voting power is transferred.Notwithstanding the above, a Change in Control shall not be deemed to occur on account of the sale or acquisition of the Company’s capital stock by institutionalinvestors or venture capital firms for the primary purpose of obtaining financing for the Company.6. No Mitigation . Executive shall have no obligation to mitigate any amount of any payment or benefit contemplated by this agreement.7. Cooperation . For one month following termination of the Executive’s employment for any reason, and, additionally, for the number of months for whichthe Executive is receiving severance following termination, he will reasonably cooperate with the Company in all matters relating to the winding up of his pendingwork including, but not limited to, any litigation in which the Company is involved, and the orderly transfer of any such pending work to such other employees asmay be designated by the Company. The Company will reimburse the Executive for any out-of-pocket expenses associated with such cooperation.8. Insurance and Indemnification . The Company shall purchase a directors and officers insurance policy for which Executive shall receive usual andcustomary coverage for all acts undertaken as an officer of the Company. In addition, the Company shall indemnify Executive to the fullest extent permitted by itscharter, bylaws and by law for all costs, charges, damages, fees including without limitation, attorneys fees or other expenses that Executive incurs or potentiallymay incur in connection with Executives’ duties herewith and also enter into an indemnification agreement with Executive. 79. Pronouns . Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms,and the singular forms of nouns and pronouns shall include the plural, and vice versa.10. Complete Agreement . This Agreement constitutes the entire agreement between Executive and the Company with regard to the subject matter hereof.This Agreement is the complete, final, and exclusive embodiment of their agreement with regard to this subject matter and supersedes any prior oral discussions orwritten communications and agreements. This Agreement is entered into without reliance on any promise or representation other than those expressly containedherein, and it cannot be modified or amended except in writing signed by Executive and an authorized officer of the Company. The parties have entered into aseparate Proprietary Information, Inventions, and Non-Competition Agreement and have or may enter into separate equity grant agreements. These separateagreements govern other aspects of the relationship between the parties, have or may have provisions that survive termination of the Executive’s employment underthis Agreement, may be amended or superseded by the parties without regard to this agreement and are enforceable according to their terms without regard to theenforcement provision of this Agreement. In the event of a conflict between this Agreement and any other agreement between the Executive and the Company, thisAgreement shall control.11. Amendment . This Agreement may be amended or modified only by a written instrument executed by both the Company and Executive.12. Governing Law . This Agreement shall be construed, interpreted and enforced in accordance with the laws of the State of New York and any actionarising from or relating to this Agreement shall be commenced in the Federal or State courts located in New York County.13. Notices . Any notices required hereunder to be in writing shall be deemed effectively given: (a) upon personal delivery to the party to be notified;(b) when sent by electronic mail, telex or confirmed facsimile if sent during normal business hours on the day sent, and, if not, then on the next business day;(c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationallyrecognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the Company at its primaryoffice location and to Employee at Employee’s address as listed on the Company payroll, or at such other address as the Company or the Employee may designateby ten (10) days advance written notice to the other.14. Successors and Assigns .14.1 Assumption by Successors . The Company shall require any successor (whether direct or indirect, by purchase, merger, consolidation orotherwise and whether or not after a Change in Control) to all or substantially all of the business or assets of the Company to assume in writing prior to suchsuccession and to agree to perform its obligations under this Agreement in the same manner and to the same extent that the Company would be required to performit if no such succession had taken place. Successions by virtue of the sale of stock shall be governed by operation of law. 814.2 Successor Benefits . This Agreement shall be binding upon and inure to the benefit of both parties and their respective successors and assigns,including any corporation into which the Company may be merged or which may succeed to its assets or business, provided, however , that the obligations ofExecutive are personal and shall not be assigned by Executive.15. Miscellaneous .15.1 No Waiver . No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any otherright. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar or waiver of anyright on any other occasion.15.2 Captions . The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope orsubstance of any section of this Agreement.15.3 Severability . In case any provision of this Agreement shall be invalid, illegal or otherwise unenforceable, the validity, legality and enforceabilityof the remaining provisions shall in no way be affected or impaired thereby.15.4 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original but all of which togethershall constitute one and the same instrument.IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year set forth above. I NTRA - CELLULAR T HERAPIES , I NC . E XECUTIVEBy: /s/ Lawrence Hineline /s/ Robert Davis L AWRENCE H INELINE R OBERT D AVIS C HIEF F INANCIAL OFFICER S ENIOR V ICE P RESIDENT , C HIEF S CIENTIFIC O FFICER 9S CHEDULE AP ERMITTED A CTIVITIES 10SCHEDULE BR ELEASE OF C LAIMSThis Release of Claims ( Release ”) is made as of by and between (“ the Executive ”) and Intra-Cellular Therapies, Inc. (the “Company ”) (together, the “ Parties ”).1. In consideration for Executive’s execution of this Release, the Company will make a severance payment to Executive in the amount set forth in theEmployment Agreement between the Executive and the Company. This amount will be paid following the Effective Date (as defined below) in accordance with theEmployment Agreement, provided the Company has received the executed Agreement from Executive on or before that date. This payment will be subject tostandard payroll deductions and withholdings. If Executive timely elects and remains eligible for continued coverage under COBRA, the Company will pay thatportion of Executive’s COBRA premiums it was paying prior to the Separation Date for the time period set forth in the Employment Agreement between theExecutive and the Company.2. Executive hereby releases, acquits and forever discharges the Company, its parents and subsidiaries, and their officers, directors, agents, servants,employees, stockholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys fees,damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, which were known or through reasonable diligence should have beenknown, arising out of or in any way related to Releases, events, acts or conduct at any time prior to the date Executive executes this Settlement Release, including,but not limited to: all such claims and demands directly or indirectly arising out of or in any way connected with Executive’s employment with the Company,including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demandsrelated to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expensereimbursements, severance pay, or any other form of compensation; claims pursuant to any federal, state or local law or cause of action including, but not limitedto, any and all claims and causes of action that the Company, its parents and subsidiaries, and its and their respective officers, directors, agents, servants,employees, attorneys, shareholders, successors, assigns or affiliates: • has violated its personnel policies, handbooks, contracts of employment, or covenants of good faith and fair dealing; • has discriminated against him on the basis of age, race, color, sex (including sexual harassment), national origin, ancestry, disability, religion, sexualorientation, marital status, parental status, source of income, entitlement to benefits, any union activities or other protected category in violation of anylocal, state or federal law, constitution, ordinance, or regulation, including but not limited to: Title VII of the Civil Rights Act of 1964, as amended; 42U.S.C. § 1981, as amended; the Equal Pay Act; the Americans With Disabilities Act; the Family and Medical Leave Act; the New York State LawHuman Rights Law; the New York City Human Rights Law; the Employee Retirement Income Security Act; Section 510; and the National LaborRelations Act; 11 • has violated any statute, public policy or common law (including but not limited to claims for retaliatory discharge; negligent hiring, retention orsupervision; defamation; intentional or negligent infliction of emotional distress and/or mental anguish; intentional interference with contract;negligence; detrimental reliance; loss of consortium to him or any member of his family and/or promissory estoppel).Excluded from this Release are any claims which cannot be waived by law. Executive is waiving, however, his right to any monetary recovery should anygovernmental agency or entity, such as the EEOC or the DOL, pursue any claims on his behalf. Executive acknowledges that he is knowingly and voluntarilywaiving and releasing any rights he may have under the ADEA, as amended. Executive also acknowledges that (i) the consideration given to his in exchange for thewaiver and release in this Release is in addition to anything of value to which he was already entitled, and (ii) that he has been paid for all time worked, havereceived all the leave, leaves of absence and leave benefits and protections for which he is eligible, and have not suffered any on-the-job injury for which he has notalready filed a claim. Executive further acknowledges that he has been advised by this writing that: (a) his waiver and release do not apply to any rights or claimsthat may arise after the execution date of this Release; (b) he has been advised hereby that he has the right to consult with an attorney prior to executing thisRelease; (c) he has twenty-one (21) days to consider this Release (although Executive may choose to voluntarily execute this Release earlier and if he does he willsign the Consideration Period waiver below); (d) he has seven (7) days following his execution of this Release to revoke the Release; and (e) this Release shall notbe effective until the date upon which the revocation period has expired unexercised (the “Effective Date”), which shall be the eighth day after Executive executesthis Release.3. On or before the last day of Executive’s employment, Executive agrees to return to the Company all Company documents (and all copies thereof) andother Company property that Executive has had in his possession at any time, including, but not limited to, Company files, notes, drawings, records, business plansand forecasts, financial information, specifications, computer-recorded information, tangible property (including, but not limited to, computers), credit cards, entrycards, identification badges and keys; and, any materials of any kind that contain or embody any proprietary or confidential information of the Company (and allreproductions thereof). Executive shall coordinate the return of Company property with Allen Fienberg, Vice President of Business Development or anappropriated officer designated by the Board of Directors.4. Executive further agrees that both during and after Executive’s employment Executive acknowledges his continuing obligations under his ProprietaryInformation, Inventions and Non-Competition Agreement not to use or disclose any confidential or proprietary information of the Company and to refrain fromcertain solicitation and competitive activities.5. It is understood that Executive shall hold the provisions of this Release in strictest confidence and shall not publicize or disclose it in any mannerwhatsoever; provided, however , that: (a) Executive may disclose this Release to his immediate family; (b) Executive may disclose this Release in confidence to hisattorney, accountant, auditor, tax preparer, and financial advisor; and (c) Executive may disclose this Release insofar as such disclosure may be required by law. 126. Executive agrees not to disparage the Company, and the Company’s attorneys, directors, managers, partners, employees, agents and affiliates, in anymanner likely to be harmful to them or their business, business reputation or personal reputation; provided that Executive may respond accurately and fully to anyquestion, inquiry or request for information when required by legal process.7. This Release does not constitute an admission by the Company of any wrongful action or violation of any federal, state, or local statute, or common lawrights, including those relating to the provisions of any law or statute concerning employment actions, or of any other possible or claimed violation of law or rights.8. Executive agrees that upon any breach of this Release Executive will forfeit all amounts paid or owing to Executive under this Release. Executive furtheracknowledges that it may be impossible to assess the damages caused by violation of the terms of paragraphs 3, 4, 5 and 6 of this Release and further agree that anythreatened or actual violation or breach of those paragraphs of this Release will constitute immediate and irreparable injury to the Company. Executive thereforeagrees that any such breach of this Release is a material breach of this Release, and, in addition to any and all other damages and remedies available to theCompany upon Executive’s breach of this Release, the Company shall be entitled to an injunction to prevent Executive from violating or breaching this Release.Executive agrees that if the Company is successful in whole or part in any legal or equitable action against Executive under this Release, Executive agree to pay allof the costs, including reasonable attorney’s fees, incurred by the Company in enforcing the terms of this Release.9. This Release constitutes the complete, final and exclusive embodiment of the entire Release between the Parties with regard to this subject matter. It isentered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and it supersedes any other suchpromises, warranties or representations. This Release may not be modified or amended except in a writing signed by both Executive and a duly authorized officerof the Company. This Release will bind the heirs, personal representatives, successors and assigns of the Parties, and inure to the benefit of the Parties, their heirs,successors and assigns. If any provision of this Release is determined to be invalid or unenforceable, in whole or in part, this determination will not affect any otherprovision of this Release and the provision in question will be modified by the court so as to be rendered enforceable. This Release will be deemed to have beenentered into and will be construed and enforced in accordance with the laws of the State of New York as applied to contracts made and to be performed entirelywithin New York.I N W ITNESS W HEREOF , the Parties have duly authorized and caused this Agreement to be executed as follows: I NTRA -C ELLULAR T HERAPIES , I NC . By: [NAME] [N AME ] Date Date 13Exhibit 10.7EMPLOYMENT AGREEMENTTHIS EMPLOYMENT AGREEMENT (the “Agreement”), is effective this 5th day of November, 2015 (the “Effective Date”) between Kimberly Vanover(“Executive”) and Intra-Cellular Therapies, Inc. (the “Company”).1. Title; Capacity . Subject to terms set forth herein, the Company agrees to employ Executive in the position of Senior Vice President, ClinicalDevelopment. Executive shall serve in an executive capacity and shall perform such duties as are assigned to Executive from time to time, consistent with theBylaws of the Company and as required by the Company’s Board of Directors (the “Board”). During the term of her employment with the Company, Executivewill devote her best efforts and substantially all of her business time and attention to the business of the Company. Notwithstanding the foregoing, or any otherprovision of this Agreement, it shall not be a breach or violation of this Agreement for the Executive to (i) serve on civic or charitable boards or committees,(ii) with the express written permission of the Company serve on corporate boards of companies that do not present a conflict of interest or compete directly orindirectly with the Company, (iii) deliver lectures, fulfill speaking engagements or teach at educational institutions, or (iv) manage personal investments, so long assuch activities do not significantly interfere with or significantly detract from the performance of the Executive’s responsibilities to the Company in accordancewith this Agreement. The Board has approved the Executive’s participation in the activities listed on Schedule A to this Agreement.2. Term . The term of this Agreement shall commence on the Effective Date, and shall continue for three (3) years from that date, unless terminated priorthereto by either the Company or the Executive as provided in Section 4. If either the Company or the Executive does not wish to renew this Agreement when itexpires at the end of the initial or any renewal term hereof, as hereinafter provided, or if either the Company or the Executive wishes to renew this Agreement ondifferent terms than those contained herein, it or she shall give written notice in accordance with Section 13 below of such intent to the other party at least sixty(60) days prior to the expiration date. In the absence of such notice, this Agreement shall be renewed on the same terms and conditions contained herein for a termof one year from the date of expiration. The parties expressly agree that designation of a term and renewal provisions in this Agreement does not in any way limitthe right of the parties to terminate this Agreement at any time as hereinafter provided. Reference herein to the term of this Agreement shall refer both to the initialterm and any successive term as the context requires. Should the Company elect not to renew this Agreement for reasons other than death or Disability (as definedin Section 4.3 below), or Cause (as defined in Section 4.1 below), the Executive shall be eligible for the same severance payments and benefits as Executive wouldreceive under Section 5.2 and on the same conditions as if Executive had been terminated by the Company without Cause, provided that Executive executes aRelease of claims in favor of the Company as defined in Section 5.2(a). Provided however , Executive shall not receive any such severance payments and benefitsunless she executes the Release within the consideration period specified therein and until the Release becomes effective and can no longer be revoked byExecutive under its terms. Executive’s ability to receive such payment and benefits is further conditioned upon her: returning all Company property; complyingwith her post termination obligations under this Agreement and the Proprietary Information, Inventions, and Non-Competition Agreement between the Executive 1and the Company; and complying with the Release including without limitation any non-disparagement and confidentiality provisions contained therein. Executiveshall not be eligible for any severance payments and benefits if either the Executive or the Company wishes to renew this Agreement on different terms than thosecontained herein.3. Compensation and Benefits .3.1 Salary . Executive will receive for Executive’s services to be rendered under this Agreement an initial annualized base salary at the rate of$340,000 per year, subject to annual review and adjustment by the Company in the discretion of the Board, payable subject to standard federal and state payrollwithholding requirements in accordance with the Company’s standard payroll practices (“ Base Salary ”).3.2 Incentive Compensation . In addition to Executive’s Base Salary, the Executive shall be eligible during the term of this Agreement for such bonuspayments and/or equity grants as awarded to the Executive by the Board.3.3 Policies and Fringe Benefits . The employment relationship between the parties shall also be subject to the Company’s personnel policies andprocedures as they may be interpreted, adopted, revised or deleted from time to time in the Company’s sole discretion. The Executive will be eligible to participateon the same basis as other executive level employees in the Company’s benefit plans in effect from time to time during her employment. All matters of eligibilityfor coverage or benefits under any benefit plan shall be determined in accordance with the provisions of such plan. The Company reserves the right to change, alter,or terminate any benefit plan in its sole discretion. While this Agreement is in effect, the Company will provide the Executive with life insurance, for which theExecutive may designate the beneficiary or beneficiaries in an amount of $150,000, and long-term disability insurance.3.4 Reimbursement of Certain Expenses . The Company will reimburse Executive for reasonable business expenses in accordance with the Company’sexpense reimbursement policies.4. Termination of Employment . Either Executive or the Company may terminate the employment relationship at any time, for any reason, in accordancewith this Section 4.4.1 Termination for Cause . At the election of the Company, the employment relationship may be terminated for Cause upon written notice by theCompany to Executive specifying the provision or provisions of this Section 4.1 upon which the decision to terminate is based. For the purposes of this Section 4.1,“Cause” for termination shall be deemed to exist upon the occurrence of any of the following:(a) a good faith finding by the Company that Executive has engaged in gross negligence or gross misconduct that is materially injurious to theCompany;(b) Executive’s conviction of a felony or crime involving fraud or embezzlement of Company property; 2(c) Executive’s material breach of this Agreement which, if curable, has not been cured by Executive within 60 days after she shall have receivedwritten notice from the Company stating with reasonable specificity the nature of such breach;(d) material breach of fiduciary duty; or(e) refusal to follow or implement a clear and reasonable directive of the Board as a whole, or an officer of the Company, provided that such directiveis ethical and legal and which, if curable, has not been cured by Executive within 60 days after she shall have received written notice from the Company statingwith reasonable specificity the nature of such refusal.4.2 Termination by the Company Without Cause or by the Executive for Good Reason . At the election of the Company it may terminate Executive’semployment for reasons other than Cause, death or Disability, at any time upon written notice by the Company to Executive. The Executive may resign fromExecutive’s employment for “Good Reason” within sixty (60) days after the occurrence of one of the events specified below, by giving prior written notice,provided that Executive has not consented in writing to one of the specified events or been notified previously of the Company’s intention to terminate Executive’semployment. As used in this Agreement Good Reason shall mean:(a) The assignment to Executive of any duties or responsibilities which result in the material diminution of Executive’s position;(b) a 5% or greater reduction by the Company in Executive’s annual Base Salary;(c) a material change in the geographic location at which the Executive is required to perform services; or(d) material breach by the Company of any material provision of this Agreement ; provided however , that any actions taken by the Company toaccommodate a disability of the Executive or pursuant to the Family and Medical Leave Act shall not be a Good Reason for purposes of this Agreement.Notwithstanding the occurrence of any of the events enumerated in Section 4.2 (a) through (d), such occurrence shall not be deemed to constitute Good Reason if,within 30 days after the giving by Executive of notice of the occurrence or existence of an event or circumstance specified above, such event or circumstance hasbeen fully corrected (provided that such right of correction by the Company shall only apply to the first such notice given by Executive). In the absence of suchcorrection, Executive’s resignation shall be effective thirty (30) days following the Executive’s notice.4.3 Death or Disability . The Executive’s employment will terminate upon the death or determination of disability of Executive. As used in thisAgreement, the determination of “disability” shall occur when the Executive is unable due to a physical or mental condition to perform the essential functions ofher position with or without reasonable accommodation for 90 consecutive days, or 180 days in the aggregate whether or not consecutive, during any 360-dayperiod, or based on the written certification by a licensed physician of the likely continuation of such condition for such period. A determination of disability shallbe made by a physician satisfactory to both Executive and the Company, provided that if Executive and the Company do 3not agree on a physician, Executive and the Company shall each select a physician and these two together shall select a third physician, whose determination as todisability shall be binding on all parties. This definition shall be interpreted and applied consistent with the Americans with Disabilities Act, the Family andMedical Leave Act, and other applicable law.4.4 Termination by Executive without Good Reason . At the election of Executive, she may terminate employment upon not less than 30 days priorwritten notice by Executive to the Company.5. Effect of Termination .5.1 General; Termination for Cause or by the Executive Without Good Reason . In the event that Executive’s employment is terminated for anyreason, the Company shall pay to Executive the compensation and benefits, including payment for accrued but untaken vacation days, payable to Executive throughthe last day of Executive’s actual employment by the Company. If the termination is by the Company for Cause pursuant to Section 4.1 or at the election ofExecutive pursuant to Section 4.4, the Company shall have no further obligations under this Agreement.5.2 Termination by the Company Without Cause or by the Executive for Good Reason .(a) Employee shall not receive any of the benefits pursuant to this Section 5.2 unless she executes a general release in favor of the Company, in a formacceptable to the Company and substantially similar to the form attached hereto as Schedule B ( the “Release”) within the consideration period specified therein(the “Release Review Period”) and until the Release becomes effective and can no longer be revoked by Employee under its terms. Employee’s ability to receivebenefits pursuant to this Section 5.2 is further conditioned upon her: returning all Company property; complying with her post termination obligations under thisAgreement and the Proprietary Information, Inventions and Non-Competition Agreement; and complying with the Release including without limitation any non-disparagement and confidentiality provisions contained therein.(b) In the event that Executive’s employment is terminated pursuant to Section 4.2 by the Company without Cause or by the Executive for GoodReason, the Company shall pay to Executive as severance twelve months of her annual Base Salary then in effect, together with an additional amount calculated bydividing by 365 the number of days employed in the year of termination and multiplying that number by the amount of the Executive’s previous year’s bonus (ifany), such amount to be paid in one lump sum on the date the Release becomes effective, subject to standard payroll deductions and withholdings, provided,however, that if the Release Review Period begins in one tax year and ends in a later tax year, the payments under this Section 5.2(b) will be made following thedate that the Release is effective that occurs in the later tax year . Additionally, if Executive timely elects and remains eligible for continued coverage underCOBRA, the Company, as part of this Agreement, will pay that portion of Executive’s COBRA premiums it was paying prior to the Separation Date for twelve(12) months. 4(c) In the event Executive’s employment is terminated pursuant to Section 4.2, and not for Cause, death or Disability, all unvested equity awards shallbecome fully vested, all unvested stock options shall become fully vested and exercisable and any ISO’s issued to Executive will automatically convert to a non-qualified options on the 91 st day following termination, provided it has not been exercised, subject to the terms of the applicable stock plan and option agreement.(d) Termination for Death or Disability . In the event that Executive’s employment is terminated by death or because of Disability pursuant toSection 4.3, in addition to the payment of accrued salary and unused vacation provided in Section 5.1, the Company shall pay to Executive’s estate or to Executive,as the case may be, compensation which would otherwise be payable to Executive through the end of the month in which such termination occurs, and payment forany accrued but untaken vacation days.5.3 Code Sections 409A and 280G .(a) In the event that the payments or benefits set forth in Section 5.2 of this Agreement constitute “non-qualified deferred compensation” subject toSection 409A of the Internal Revenue Code of 1986, as amended (the “Code”), then the following conditions apply to such payments or benefits:(i) Any termination of Executive’s employment triggering payment of benefits under Section 5 must constitute a “separation from service”under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h) before distribution of such benefits can commence. To the extent that thetermination of Executive’s employment does not constitute a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg.§1.409A-1(h) (as the result of further services that are reasonably anticipated to be provided by Executive to Company at the time Executive’semployment terminates), any such payments under Section 5 that constitute deferred compensation under Section 409A of the Code shall be delayeduntil after the date of a subsequent event constituting a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h). For purposes of clarification, this Section 5.3(a) shall not cause any forfeiture of benefits on Executive’s part, but shall only act as a delay untilsuch time as a “separation from service” occurs.(ii) Notwithstanding any other provision with respect to the timing of payments under Section 5.2 if, at the time of Executive’s termination, Executiveis deemed to be a “specified employee” of Company (within the meaning of Section 409A(a)(2)(B)(i) of the Code), then limited only to the extentnecessary to comply with the requirements of Section 409A of the Code, any payments to which Executive may become entitled under Section 5which are subject to Section 409A of the Code (and not otherwise exempt from its application) shall be withheld until the first (1 st ) business day ofthe seventh (7 th ) month following the termination of Executive’s employment, at which time Executive shall be paid an aggregate amount equal tothe accumulated, but unpaid, payments otherwise due to Executive under the terms of Section 5. 5(b) It is intended that each installment of the payments and benefits provided under Section 5 of this Agreement shall be treated as a separate“payment” for purposes of Section 409A of the Code. Neither Company nor Executive shall have the right to accelerate or defer the delivery of any such paymentsor benefits except to the extent specifically permitted or required by Section 409A of the Code.(c) Notwithstanding any other provision of this Agreement to the contrary, this Agreement shall be interpreted and at all times administered in amanner that avoids the inclusion of compensation in income under Section 409A of the Code, or the payment of increased taxes, excise taxes or other penaltiesunder Section 409A of the Code. The parties intend this Agreement to be in compliance with Section 409A of the Code. Executive acknowledges and agrees thatCompany does not guarantee the tax treatment or tax consequences associated with any payment or benefit arising under this Agreement, including but not limitedto consequences related to Section 409A of the Code.(d) If any payment or benefit Executive would receive under Section 5.4 of this Agreement, when combined with any other payment or benefitExecutive receives pursuant to a Change of Control (for purposes of this section, a “Payment”) would: (i) constitute a “parachute payment” within the meaning ofSection 280G the Code; and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then such Payment shallbe either: (A) the full amount of such Payment; or (B) such lesser amount (with cash payments being reduced before equity compensation) as would result in noportion of the Payment being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and localemployments taxes, income taxes, and the Excise Tax, results in Executive’s receipt, on an after-tax basis, of the greater amount of the Payment notwithstandingthat all or some portion of the Payment may be subject to the Excise Tax.5.4 Effect of a Change in Control .(a) In the event either (i) Executive’s employment with the Company is terminated by the Company for reasons other than death or Disability (asdefined above) within three months before or 12 months following a Change in Control (as defined below) or (ii) Executive terminates her employment for GoodReason (as defined above) within three months before or 12 months following a Change in Control (as defined below), or (iii) the Executive terminates heremployment for any reason within one (1) month following a Change in Control (as defined below), then provided that Executive executes the Release (as definedin Section 5.2) within the consideration period specified therein and it becomes effective and can no longer be revoked by Executive under its terms, and providedfurther that Executive returns all Company property’ complies with her post termination obligations under this Agreement and the Proprietary Information,Inventions and Non-Competition Agreement, and complies with the Release including without limitation any non-disparagement and confidentiality provisionscontained therein, Executive shall be entitled to the payments, equity acceleration and benefits described in this Section 5.4 in lieu of, and not in addition to, thebenefits provided for in Section 5.2. The Company shall pay to the Executive, in lieu of the severance described in Section 5.2(a), severance equivalent to 18months of her annual Base Salary then in effect, together with an additional amount calculated by dividing by 365 the number of days employed in the year oftermination and multiplying that number by the amount of the Executive’s previous year’s bonus 6(if any), paid in a lump sum on the eighth day following the date the Release becomes effective, subject to standard payroll deductions and withholdings, provided,however, that if the Release Review Period begins in one tax year and ends in a later tax year, the payments under this Section 5.4(a) will be made following thedate that the Release is effective that occurs in the later tax year. On the date of termination of Executive’s employment, any unvested equity awards granted to theExecutive shall immediately vest and, in the case of stock options, become exercisable. Additionally, if Executive timely elects and remains eligible for continuedcoverage under COBRA, the Company, as part of this Agreement, will pay that portion of Executive’s COBRA premiums it was paying prior to the SeparationDate for eighteen (18) months.(b) Definition of Change in Control . For purposes of this Agreement, a “Change in Control” means the occurrence of any of the following events:(i) a sale, lease or other disposition of all or substantially all of the assets of the Company;(ii) a consolidation or merger of the Company with or into any other corporation or other entity or person, or any other corporate reorganization,in which the stockholders of the Company immediately prior to such consolidation, merger or reorganization, own less than fifty percent (50%) of theoutstanding voting power of the surviving entity (and its parent) following the consolidation, merger or reorganization; or(iii) any transaction (or series of related transactions involving a person or entity, or a group of affiliated persons or entities) in which in excessof fifty percent (50%) of the Company’s outstanding voting power is transferred.Notwithstanding the above, a Change in Control shall not be deemed to occur on account of the sale or acquisition of the Company’s capital stock by institutionalinvestors or venture capital firms for the primary purpose of obtaining financing for the Company.6. No Mitigation . Executive shall have no obligation to mitigate any amount of any payment or benefit contemplated by this agreement.7. Cooperation . For one month following termination of the Executive’s employment for any reason, and, additionally, for the number of months for whichthe Executive is receiving severance following termination, she will reasonably cooperate with the Company in all matters relating to the winding up of her pendingwork including, but not limited to, any litigation in which the Company is involved, and the orderly transfer of any such pending work to such other employees asmay be designated by the Company. The Company will reimburse the Executive for any out-of-pocket expenses associated with such cooperation.8. Insurance and Indemnification . The Company shall purchase a directors and officers insurance policy for which Executive shall receive usual andcustomary coverage for all acts undertaken as an officer of the Company. In addition, the Company shall indemnify Executive to the fullest extent permitted by itscharter, bylaws and by law for all costs, charges, damages, fees including without limitation, attorneys fees or other expenses that Executive incurs or potentiallymay incur in connection with Executives’ duties herewith and also enter into an indemnification agreement with Executive. 79. Pronouns . Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms,and the singular forms of nouns and pronouns shall include the plural, and vice versa.10. Complete Agreement . This Agreement constitutes the entire agreement between Executive and the Company with regard to the subject matter hereof.This Agreement is the complete, final, and exclusive embodiment of their agreement with regard to this subject matter and supersedes any prior oral discussions orwritten communications and agreements. This Agreement is entered into without reliance on any promise or representation other than those expressly containedherein, and it cannot be modified or amended except in writing signed by Executive and an authorized officer of the Company. The parties have entered into aseparate Proprietary Information, Inventions, and Non-Competition Agreement and have or may enter into separate equity grant agreements. These separateagreements govern other aspects of the relationship between the parties, have or may have provisions that survive termination of the Executive’s employment underthis Agreement, may be amended or superseded by the parties without regard to this agreement and are enforceable according to their terms without regard to theenforcement provision of this Agreement. In the event of a conflict between this Agreement and any other agreement between the Executive and the Company, thisAgreement shall control.11. Amendment . This Agreement may be amended or modified only by a written instrument executed by both the Company and Executive.12. Governing Law . This Agreement shall be construed, interpreted and enforced in accordance with the laws of the State of New York and any actionarising from or relating to this Agreement shall be commenced in the Federal or State courts located in New York County.13. Notices . Any notices required hereunder to be in writing shall be deemed effectively given: (a) upon personal delivery to the party to be notified;(b) when sent by electronic mail, telex or confirmed facsimile if sent during normal business hours on the day sent, and, if not, then on the next business day;(c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationallyrecognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the Company at its primaryoffice location and to Employee at Employee’s address as listed on the Company payroll, or at such other address as the Company or the Employee may designateby ten (10) days advance written notice to the other.14. Successors and Assigns .14.1 Assumption by Successors . The Company shall require any successor (whether direct or indirect, by purchase, merger, consolidation orotherwise and whether or not after a Change in Control) to all or substantially all of the business or assets of the Company to assume in writing prior to suchsuccession and to agree to perform its obligations under this Agreement in the same manner and to the same extent that the Company would be required to performit if no such succession had taken place. Successions by virtue of the sale of stock shall be governed by operation of law. 814.2 Successor Benefits . This Agreement shall be binding upon and inure to the benefit of both parties and their respective successors and assigns,including any corporation into which the Company may be merged or which may succeed to its assets or business, provided, however , that the obligations ofExecutive are personal and shall not be assigned by Executive.15. Miscellaneous .15.1 No Waiver . No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any otherright. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar or waiver of anyright on any other occasion.15.2 Captions . The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope orsubstance of any section of this Agreement.15.3 Severability . In case any provision of this Agreement shall be invalid, illegal or otherwise unenforceable, the validity, legality and enforceabilityof the remaining provisions shall in no way be affected or impaired thereby.15.4 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original but all of which togethershall constitute one and the same instrument.IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year set forth above. I NTRA - CELLULAR T HERAPIES , I NC . E XECUTIVEBy: /s/ Lawrence Hineline /s/ Kimberly Vanover L AWRENCE H INELINE K IMBERLY V ANOVER C HIEF F INANCIAL OFFICER S ENIOR V ICE P RESIDENT , C LINICAL D EVELOPMENT 9S CHEDULE AP ERMITTED A CTIVITIES 10SCHEDULE BR ELEASE OF C LAIMSThis Release of Claims ( Release ”) is made as of by and between (“ the Executive ”) and Intra-Cellular Therapies, Inc. (the “Company ”)(together, the “ Parties ”).1. In consideration for Executive’s execution of this Release, the Company will make a severance payment to Executive in the amount set forth in theEmployment Agreement between the Executive and the Company. This amount will be paid following the Effective Date (as defined below) in accordance with theEmployment Agreement, provided the Company has received the executed Agreement from Executive on or before that date. This payment will be subject tostandard payroll deductions and withholdings. If Executive timely elects and remains eligible for continued coverage under COBRA, the Company will pay thatportion of Executive’s COBRA premiums it was paying prior to the Separation Date for the time period set forth in the Employment Agreement between theExecutive and the Company.2. Executive hereby releases, acquits and forever discharges the Company, its parents and subsidiaries, and their officers, directors, agents, servants,employees, stockholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys fees,damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, which were known or through reasonable diligence should have beenknown, arising out of or in any way related to Releases, events, acts or conduct at any time prior to the date Executive executes this Settlement Release, including,but not limited to: all such claims and demands directly or indirectly arising out of or in any way connected with Executive’s employment with the Company,including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demandsrelated to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expensereimbursements, severance pay, or any other form of compensation; claims pursuant to any federal, state or local law or cause of action including, but not limitedto, any and all claims and causes of action that the Company, its parents and subsidiaries, and its and their respective officers, directors, agents, servants,employees, attorneys, shareholders, successors, assigns or affiliates: • has violated its personnel policies, handbooks, contracts of employment, or covenants of good faith and fair dealing; • has discriminated against her on the basis of age, race, color, sex (including sexual harassment), national origin, ancestry, disability, religion, sexualorientation, marital status, parental status, source of income, entitlement to benefits, any union activities or other protected category in violation of anylocal, state or federal law, constitution, ordinance, or regulation, including but not limited to: Title VII of the Civil Rights Act of 1964, as amended; 42U.S.C. § 1981, as amended; the Equal Pay Act; the Americans With Disabilities Act; the Family and Medical Leave Act; the New York State LawHuman Rights Law; the New York City Human Rights Law; the Employee Retirement Income Security Act; Section 510; and the National LaborRelations Act; 11 • has violated any statute, public policy or common law (including but not limited to claims for retaliatory discharge; negligent hiring, retention orsupervision; defamation; intentional or negligent infliction of emotional distress and/or mental anguish; intentional interference with contract;negligence; detrimental reliance; loss of consortium to her or any member of her family and/or promissory estoppel).Excluded from this Release are any claims which cannot be waived by law. Executive is waiving, however, her right to any monetary recovery should anygovernmental agency or entity, such as the EEOC or the DOL, pursue any claims on her behalf. Executive acknowledges that she is knowingly and voluntarilywaiving and releasing any rights she may have under the ADEA, as amended. Executive also acknowledges that (i) the consideration given to her in exchange forthe waiver and release in this Release is in addition to anything of value to which she was already entitled, and (ii) that she has been paid for all time worked, havereceived all the leave, leaves of absence and leave benefits and protections for which she is eligible, and have not suffered any on-the-job injury for which she hasnot already filed a claim. Executive further acknowledges that she has been advised by this writing that: (a) her waiver and release do not apply to any rights orclaims that may arise after the execution date of this Release; (b) she has been advised hereby that she has the right to consult with an attorney prior to executingthis Release; (c) she has twenty-one (21) days to consider this Release (although Executive may choose to voluntarily execute this Release earlier and if she doesshe will sign the Consideration Period waiver below); (d) she has seven (7) days following her execution of this Release to revoke the Release; and (e) this Releaseshall not be effective until the date upon which the revocation period has expired unexercised (the “Effective Date”), which shall be the eighth day after Executiveexecutes this Release.3. On or before the last day of Executive’s employment, Executive agrees to return to the Company all Company documents (and all copies thereof) andother Company property that Executive has had in her possession at any time, including, but not limited to, Company files, notes, drawings, records, business plansand forecasts, financial information, specifications, computer-recorded information, tangible property (including, but not limited to, computers), credit cards, entrycards, identification badges and keys; and, any materials of any kind that contain or embody any proprietary or confidential information of the Company (and allreproductions thereof). Executive shall coordinate the return of Company property with Allen Fienberg, Vice President of Business Development or anappropriated officer designated by the Board of Directors.4. Executive further agrees that both during and after Executive’s employment Executive acknowledges her continuing obligations under her ProprietaryInformation, Inventions and Non-Competition Agreement not to use or disclose any confidential or proprietary information of the Company and to refrain fromcertain solicitation and competitive activities.5. It is understood that Executive shall hold the provisions of this Release in strictest confidence and shall not publicize or disclose it in any mannerwhatsoever; provided, however , that: (a) Executive may disclose this Release to her immediate family; (b) Executive may disclose this Release in confidence toher attorney, accountant, auditor, tax preparer, and financial advisor; and (c) Executive may disclose this Release insofar as such disclosure may be required by law. 126. Executive agrees not to disparage the Company, and the Company’s attorneys, directors, managers, partners, employees, agents and affiliates, in anymanner likely to be harmful to them or their business, business reputation or personal reputation; provided that Executive may respond accurately and fully to anyquestion, inquiry or request for information when required by legal process.7. This Release does not constitute an admission by the Company of any wrongful action or violation of any federal, state, or local statute, or common lawrights, including those relating to the provisions of any law or statute concerning employment actions, or of any other possible or claimed violation of law or rights.8. Executive agrees that upon any breach of this Release Executive will forfeit all amounts paid or owing to Executive under this Release. Executive furtheracknowledges that it may be impossible to assess the damages caused by violation of the terms of paragraphs 3, 4, 5 and 6 of this Release and further agree that anythreatened or actual violation or breach of those paragraphs of this Release will constitute immediate and irreparable injury to the Company. Executive thereforeagrees that any such breach of this Release is a material breach of this Release, and, in addition to any and all other damages and remedies available to theCompany upon Executive’s breach of this Release, the Company shall be entitled to an injunction to prevent Executive from violating or breaching this Release.Executive agrees that if the Company is successful in whole or part in any legal or equitable action against Executive under this Release, Executive agree to pay allof the costs, including reasonable attorney’s fees, incurred by the Company in enforcing the terms of this Release.9. This Release constitutes the complete, final and exclusive embodiment of the entire Release between the Parties with regard to this subject matter. It isentered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and it supersedes any other suchpromises, warranties or representations. This Release may not be modified or amended except in a writing signed by both Executive and a duly authorized officerof the Company. This Release will bind the heirs, personal representatives, successors and assigns of the Parties, and inure to the benefit of the Parties, their heirs,successors and assigns. If any provision of this Release is determined to be invalid or unenforceable, in whole or in part, this determination will not affect any otherprovision of this Release and the provision in question will be modified by the court so as to be rendered enforceable. This Release will be deemed to have beenentered into and will be construed and enforced in accordance with the laws of the State of New York as applied to contracts made and to be performed entirelywithin New York. 13I N W ITNESS W HEREOF , the Parties have duly authorized and caused this Agreement to be executed as follows: I NTRA -C ELLULAR T HERAPIES , I NC . By: [NAME] [N AME ] Date Date 14Exhibit 10.11INTRA-CELLULAR THERAPIES, INC.EMPLOYEE PROPRIETARY INFORMATION,INVENTIONS, AND NON-COMPETITION AGREEMENTIn consideration of my employment or continued employment by I NTRA - CELLULAR T HERAPIES , I NC . (the “ Company ”), and the compensation nowand hereafter paid to me, I hereby agree as follows: 1.N ONDISCLOSURE .1.1 Recognition of Company’s Rights; Nondisclosure. At all times during my employment and thereafter, I will hold in strictest confidenceand will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information (defined below), except as such disclosure, use orpublication may be required in connection with my work for the Company, or unless an officer of the Company expressly authorizes such in writing. Iwill obtain Company’s written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to mywork at Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in suchProprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns. I have been informedand acknowledge that the unauthorized taking of the Company’s trade secrets may subject me to civil and/or criminal penalties.1.2 Proprietary Information. The term “ Proprietary Information ” shall mean any and all confidential and/or proprietary knowledge, dataor information of the Company. By way of illustration but not limitation, “ Proprietary Information ” includes (a) tangible and intangibleinformation relating to antibodies and other biological materials, cell lines, samples of assay components, media and/or cell lines and procedures andformulations for producing any such assay components, media and/or cell lines, formulations, products, processes, know-how, designs, formulas,methods, developmental or experimental work, clinical data, improvements, discoveries, plans for research, new products ( “Inventions” );(b) marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and(c) information regarding the skills and compensation of other employees of the Company. Notwithstanding the foregoing, it is understood that, at allsuch times, I am free to use information which is generally known in the trade or industry, which is not gained as result of a breach of this Agreement,and my own, skill, knowledge, know-how and experience to whatever extent and in whichever way I wish.1.3 Third Party Information. I understand, in addition, that the Company has received and in the future will receive from third partiesconfidential or proprietary information (“ Third Party Information ”) subject to a duty on the Company’s part to maintain the confidentiality of suchinformation and to use it only for certain limited purposes. During the term of my employment and thereafter, I will hold Third Party Information inthe strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with theirwork for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized by an officerof the Company in writing.1.4 No Improper Use of Information of Prior Employers and Others. During my employment by the Company I will not improperly use ordisclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation ofconfidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employeror any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person. I will use in theperformance of my duties only information which is generally known and used by persons with training and experience comparable to my own, whichis common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. 2.A SSIGNMENT OF I NVENTIONS .2.1 Proprietary Rights. The term “ Proprietary Rights ” shall mean all trade secret, patent, copyright, mask work and other intellectualproperty rights or “moral rights” throughout the world. “Moral rights” refers to any rights to claim authorship of an Invention or to object to or preventthe modification of any Invention, or to withdraw from circulation or control the publication or distribution of any Invention, and any similar right,existing under judicial or statutory law of any country in the world, or under any treaty, regardless of whether or not such right is denominated orgenerally referred to as a “moral right.”2.2 Prior Inventions. Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with theCompany are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit A (Previous Inventions)attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice or caused to beconceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property orthe property of third parties and that I wish to have excluded from the scope of this Agreement (collectively referred to as “ Prior Inventions ”). Ifdisclosure of any such Prior Invention would cause me to violate any prior confidentiality agreement, I understand that I am not to list such PriorInventions in Exhibit A but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact thatfull disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit A for such purpose. If no such disclosure isattached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into aCompany product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwidelicense (with rights to sublicense through multiple tiers of sublicensees) to make, have made, modify, use and sell such Prior Invention.Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions withoutthe Company’s prior written consent.2.3 Assignment of Inventions. Subject to Sections 2.4, and 2.6, I hereby assign and agree to assign in the future (when any such Inventions orProprietary Rights are first reduced to practice or first fixed in a tangible medium, as applicable) to the Company all my right, title and interest in andto any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes,made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with theCompany. Inventions assigned to the Company, or to a third party as directed by the Company pursuant to this Section 2, are hereinafter referred to as“ Company Inventions .”2.4 Unassigned Inventions. I recognize that this Agreement will not be deemed to require assignment of any Invention that was developedentirely on my own time without using the Company’s equipment, supplies, facilities, or trade secrets and neither related to the Company’s actual oranticipated business, research or development, nor resulted from work performed by me for the Company.2.5 Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my employmentwith the Company, I will promptly disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice by me,either alone or jointly with others. In addition, I will promptly disclose to the Company all patent applications filed by me or on my behalf within ayear after termination of employment. The Company will keep in confidence and will not use for any purpose or disclose to third parties without myconsent any confidential information disclosed in writing to the Company pursuant to this Agreement.2.6 Government or Third Party. I also agree to assign all my right, title and interest in and to any particular Company Invention to a thirdparty, including without limitation the United States, as directed by the Company.2.7 Works for Hire. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scopeof my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C.,Section 101).2.8 Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United Statesand foreign Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documentsand perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining,perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliverassignments of such Proprietary Rights to the Company or its designee. My obligation to assist the Company with respect to Proprietary Rightsrelating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shallcompensate me at a reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specifiedin the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact,which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted actsto further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any andall claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned hereunder to the Company. 3.R ECORDS . I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may berequired by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at theCompany, which records shall be available to and remain the sole property of the Company at all times. 4.D UTY OF L OYALTY D URING E MPLOYMENT . I understand that my employment with the Company requires my full attention and effort. I agreethat during the period of my employment by the Company I will not, without the Company’s express written consent, engage in any employment orbusiness activity other than for the Company, including but not limited to employment or business activity which is competitive with, or wouldotherwise conflict with, my employment by the Company. 5.N O S OLICITATION OF E MPLOYEES , C ONSULTANTS , C ONTRACTORS OR C USTOMERS . I agree that for the period of my employment by theCompany and for one (1) year after the date my employment by the Company ends for any reason, including but not limited to voluntary terminationby me or involuntary termination by the Company, I will not, either directly or through others, (i) solicit or attempt to solicit any employee of theCompany to end his or her relationship with the Company; and (ii) solicit any consultant, contractor, or customer of the Company, with whom I hadcontact or whose identity I learned as a result of my employment with the Company to diminish or materially alter its relationship with the Company.The parties agree that for purposes of this Agreement, a customer is any person or entity to which the Company has provided goods or services at any timeduring the period commencing six (6) months prior to my employment with the Company and ending on the date my employment with the Company ends. 6.N ON -C OMPETE P ROVISION . I agree that for the period of my employment with the Company, and for the period of one (1) year after the later of(1) the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company;or (2) the date a court of competent jurisdiction enters an order enforcing this provision, I will not provide services, similar to those I provided to theCompany, to any person or entity in competition (as defined below) with the Company. I acknowledge that this non-compete provision is limited tothe types of activities and services I provided in my employment with the Company.At the present time, the Company engages in the research and discovery of genes and their function, and therefore entities and individuals which providesimilar products or services are defined as in competition with the Company. The parties understand that the scope and nature of my activities and services, and theCompany’s business, products or services, may change as the Company develops. The parties agree that the scope of this provision will change to cover anychanges in my activities or services, as well as any changes in the Company’s business, products or services, during my employment. 7.N O C ONFLICTING A GREEMENT OR O BLIGATION . I represent that my performance of all the terms of this Agreement and as an employee of theCompany does not and will not breach any agreement or obligation of any kind made prior to my employment by the Company, including agreementsor obligations I may have with prior employers or entities for which I have provided services. I have not entered into, and I agree I will not enter into,any agreement or obligation either written or oral in conflict herewith. 8.R ETURN OF C OMPANY D OCUMENTS . When I leave the employ of the Company, I will deliver to the Company any and all drawings, notes,memoranda, specifications, devices, formulas, and documents, together with all copies thereof, and any other material containing or disclosing anyCompany Inventions, Third Party Information or Proprietary Information of the Company. I further agree that any property situated on the Company’spremises and owned by the Company, including disks and other storage media, filing cabinets or other work areas, is subject to inspection byCompany personnel at any time with or without notice. Prior to leaving, I will cooperate with the Company in completing and signing the Company’stermination statement. 9.L EGAL AND E QUITABLE R EMEDIES . I recognize that in the course of employment with the Company, I will have access to ProprietaryInformation, to Third Party Information, and to employees, consultants, contractors, clients, and customers of the Company. I also recognize that theservices I will be employed to provide are personal and unique. I understand that because of this the Company may sustain irreparable injury if Iviolate this Agreement. In order to limit or prevent such irreparable injury, the Company shall have the right to enforce this Agreement and any of itsprovisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and remedies that theCompany may have for a breach of this Agreement. 10.N OTICES . Any notices required or permitted hereunder shall be given to the appropriate party at the address specified below or at such other addressas the party shall specify in writing. Such notice shall be deemed given upon personal delivery to the appropriate address or if sent by certified orregistered mail, three (3) days after the date of mailing. 11.N OTIFICATION OF N EW E MPLOYER . In the event that I leave the employ of the Company, I authorize the Company to provide notice of my rightsand obligations under this Agreement to my subsequent employer and to any other entity or person to whom I provide services. 12.G ENERAL P ROVISIONS .12.1 Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the Stateof New York, as such laws are applied to agreements entered into and to be performed entirely within New York between New York residents. Ihereby expressly consent to the personal jurisdiction of the state and federal courts for New York County, New York in any lawsuit filed there againstme by Company arising from or related to this Agreement.12.2 Severability. In case any one or more of the provisions, subsections, or sentences contained in this Agreement shall, for any reason, beheld to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of thisAgreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein. Moreover, ifany one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope,activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shallthen appear.12.3 Successors and Assigns. This Agreement will be binding upon my heirs, executors, administrators and other legal representatives and willbe for the benefit of the Company, its successors, and its assigns.12.4 Survival. The provisions of this Agreement shall survive the termination of my employment and the assignment of this Agreement by theCompany to any successor in interest or other assignee.12.5 Employment At-Will. I agree and understand that I am employed at-will, and that nothing in this Agreement shall change this at-willstatus or confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with my right or theCompany’s right to terminate my employment at any time, with or without cause.12.6 Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiverby the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give noticeto enforce strict adherence to all terms of this Agreement.12.7 Entire Agreement. The obligations pursuant to Sections 1 and 2 of this Agreement shall apply to any time during which I was previouslyemployed, or am in the future employed, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventionsduring such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter hereof andsupersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under thisAgreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my duties, salary orcompensation will not affect the validity or scope of this Agreement.This Agreement shall be effective as of the first day of my employment with the Company, namely: November 4, 2015.I HAVE READ THIS AGREEMENT CAREFULLY AND UNDERSTAND ITS TERMS . I HAVE COMPLETELY FILLED OUT E XHIBIT A TO THIS A GREEMENT. Dated: November 10, 2015/s/ Robert Davis(Signature)Robert Davis(Printed Name)A CCEPTED AND A GREED T O :I NTRA - CELLULAR T HERAPIES , I NC .By: /s/ Lawrence HinelineTitle: V.P. Finance430 E. 29 th St.New York, NYDated: November 5, 2015Exhibit 14.1INTRA-CELLULAR THERAPIES, INC.CORPORATE CODE OF CONDUCT AND ETHICS ANDWHISTLEBLOWER POLICYEffective April 1, 2015INTRODUCTIONThis Corporate Code of Conduct and Ethics and Whistleblower Policy, referred to as the “Code,” is intended to provide our associates, as defined below,with a clear understanding of the principles of business conduct and ethics that are expected of them and to aid them in making ethical and legal decisions whenconducting the company’s business and performing day-to-day duties. The standards set forth in the Code apply to us all. Every associate of the company mustacknowledge his or her review of, and agreement to comply with, the Code as a condition of his or her relationship with the company (see Appendix A attachedhereto). The term “associate” as used throughout the Code means (i) every full and part-time employee of the company and its subsidiaries, (ii) all members of thecompany’s senior management, including the company’s Chief Executive Officer and Chief Financial Officer, and (iii) every member of the company’s Board ofDirectors, even if such member is not employed by the company.REPORTING VIOLATIONS UNDER THE CODE; ANTI-RETALIATION PLEDGEIt is our responsibility to conduct ourselves in an ethical business manner and also to ensure that others do the same. If any one of us violates these standards,he or she can expect a disciplinary response, up to and including termination of any employment or other relationship with the company, and possibly other legalaction. If you are aware of any breach of the Code, you are obligated to report violations to the Corporate Compliance Officer, to any member of the ComplianceCommittee, or to the anonymous Hotline that the company has retained to receive such reports, as described in more detail below. Through establishing aconfidential and anonymous option to accept and process such reports, we ensure that the good faith efforts of all of us to comply with the Code are notundermined.The Code contains a clear anti-retaliation pledge, meaning that if you in good faith report a violation of the Code by the company, or its agents acting onbehalf of the company, to the Hotline, the Corporate Compliance Officer or another member of the Compliance Committee, the company will undertake to protectyou from being fired, demoted, reprimanded or otherwise harmed for reporting the violation, even if the violation involves you, your supervisor, or seniormanagement of the company. Note, however, that while you will not be disciplined for reporting a violation, you may be subject to discipline with respect to theunderlying conduct or violation. You are entitled to make the report on a confidential and anonymous basis. To the extent an investigation must be initiated, thecompany will keep confidential any report you make to the Corporate Compliance Officer or another member of the Compliance Committee to the extent requiredby applicable law.COMPLYING WITH THE CODEThe ultimate responsibility for maintaining our Code rests with each of us. As individuals of personal integrity, we can do no less than to behave in a waythat will continue to bring credit to ourselves and our company. Applying these standards to our business lives is an extension of the values by which we are knownas individuals and by which we want to be known as a company. To that end, the company has made the Code publicly available on its web site. It is ourresponsibility to conduct ourselves in an ethical business manner and also to ensure that others do the same. If any one of us violates these standards, he or she canexpect a disciplinary response, up to and including termination of any employment or other relationship with the company, and possibly other legal action.While it is impossible for this Code to describe every situation that may arise, the standards explained in this Code are guidelines that should govern ourconduct at all times. If you are confronted with situations not covered by this Code, or have questions regarding the matters that are addressed in the Code, you areurged to consult with the Corporate Compliance Officer, a member of the Compliance Committee, or another member of management. Furthermore, the policiesset forth in this Code are in addition to other policies of the company that associates must comply with, including those set forth in the company’s EmployeeHandbook and the other policies referenced in the Code. Copies of these other policies are available from the Human Resources Department or on the company’sIntranet.The provisions of the Code regarding the actions the company will take are guidelines which the company intends to follow. There may be circumstances,however, that in the company’s judgment require different measures or actions and in such cases it may act accordingly while still attempting to fulfill theprinciples underlying this Code.In the case of any inconsistency between the provisions set out in this Code and the rules contained in any mandatory text, laws or interpretive case lawapplicable to the company and its associates, the latter prevail. In no instance should this Code be interpreted as modifying, amending or otherwise changing anylegal text and related legal precedents that apply to the company and its associates.Table of Contents Page I. WHISTLEBLOWER POLICY 1 A. Obligation to Report Violations or Suspected Violations 1 B. Whistleblower Compliance Hotline for Confidential and Anonymous Reporting 1 C. Anti-Retaliation Pledge 2 II. IMPLEMENTATION OF THE CODE 2 III. GENERAL REQUIREMENTS 4 IV. CONFLICTS OF INTEREST 4 V. PROTECTION AND PROPER USE OF COMPANY ASSETS 6 A. Proper Use of Company Property 6 B. Confidential Information 6 C. Accurate Records and Reporting 7 D. Document Retention 8 E. Corporate Advances 8 VI. FAIR DEALING WITH CUSTOMERS, SUPPLIERS, COMPETITORS, AND ASSOCIATES 9 A. Giving Gifts 9 B. Receiving Gifts 9 C. Unfair Competition 9 D. Antitrust Concerns 10 E. Unfair Practices in International Business 12 VII. GOVERNMENT RELATIONS 13 A. Government Procurement and Funding 13 B. Payments to Officials 13 C. Political Contributions 13 VIII. COMPLIANCE WITH LAWS, RULES AND REGULATIONS 14 A. Insider Trading Policy 14 B. Equal Employment Opportunity 14 C. Sexual Harassment Policy 15 D. Health, Safety & Environment Laws 15 E. Health Care Regulations 15 IX. QUESTIONS UNDER THE CODE AND WAIVER PROCEDURES 16 X. FREQUENTLY ASKED QUESTIONS AND ANSWERS (FAQ’S) REGARDING REPORTING VIOLATIONS UNDER THECODE, WHISTLEBLOWER POLICY AND HOTLINE 17 APPENDIX A ASSOCIATE’S AGREEMENT TO COMPLY 20 I.WHISTLEBLOWER POLICYA. Obligation to Report Violations or Suspected ViolationsAny associate of the company having any information or knowledge regarding the existence of any violation or suspected violation of the Code has a dutyto report the violation or suspected violation to the Whistleblower Hotline (the contact details for which are below), the Corporate Compliance Officer, or any othermember of the Compliance Committee. Associates are also encouraged to raise any issues or concerns regarding the company’s business or operations. Failure toreport suspected or actual violations is itself a violation of the Code and may subject the associate to disciplinary action, up to and including termination ofemployment or legal action. Reports may be made on a completely confidential and anonymous basis. To the extent any investigation is necessitated by a report,the company will endeavor to keep the proceedings and the identity of the reporting associate confidential to the fullest extent required by applicable law.Associates are encouraged to pursue all internal reporting channels through completion and reasonably await and consider the results of all internalinvestigations prior to reporting matters outside of the company. We have instituted the procedures described in this Code, including procedures to makeanonymous submissions (a form of internal report), to facilitate the use of internal investigations.Individuals should also consider leaving, but are not required to leave, their name or a contact number when submitting a report. Such information mayfacilitate a more thorough and efficient investigation. The Corporate Compliance Officer will strive to maintain the integrity and confidentiality of all compliance-related communications. However, in certain circumstances, the identity of the person reporting the issue may become known or may need to be revealed,particularly if federal or state enforcement authorities become involved in the investigation. The company cannot guarantee confidentiality when material evidenceof a violation of the law is disclosed or if the person is identified during the normal course of an investigation.B. Whistleblower Compliance Hotline for Confidential and Anonymous ReportingIf you are aware of any breach of the Code, you are obligated to report violations to the Corporate Compliance Officer, to any member of the ComplianceCommittee, or to the anonymous Whistleblower Compliance Hotline (the “Hotline”). The Hotline is operated by a third party service provider, which the companyhas retained to receive such reports, the contact details for which are below. You may make such reports on a completely anonymous and confidential basis bycontacting the Hotline. Associates may report to the Hotline any concerns an associate may have with respect to the company, including, but not limited to,concerns with the company’s business or operations, suspected violations of the Code, securities or antifraud laws, accounting issues, any law relating to fraudagainst shareholders, or any other issue concerning the company and their employment with the company. Reports made to the Hotline will, in turn, be provideddirectly to the Audit Committee on an anonymous and confidential basis. The Hotline may be reached 24 hours a day, 7 days a week at the following toll-freenumber and internet address:Contact Information for the Whistleblower Compliance Hotline: Toll-Free Telephone Number 866-865-9483Compliance Hotline E-mail Address INTY@openboard.infoCompliance Hotline Internet Address http://www.openboard.info/INTY/ 1C. Anti-Retaliation PledgeAny associate who in good faith reports a suspected violation under the Code by the company, or its agents acting on behalf of the company, or who ingood faith raises issues or concerns regarding the company’s business or operations, to the Hotline, the Corporate Compliance Officer or any other member of theCompliance Committee, may not be fired, demoted, reprimanded or otherwise harmed for, or because of, the reporting of the suspected violation, issues orconcerns, regardless of whether the suspected violation involves the associate, the associate’s supervisor or senior management of the company.In addition, any associate who in good faith reports a suspected violation under the Code which the associate reasonably believes constitutes a violation ofa federal statute by the company, or its agents acting on behalf of the company, to a federal regulatory or law enforcement agency, may not be reprimanded,discharged, demoted, suspended, threatened, harassed or in any manner discriminated against in the terms and conditions of the associate’s employment for, orbecause of, the reporting of the suspected violation, regardless of whether the suspected violation involves the associate, the associate’s supervisor or seniormanagement of the company. II.IMPLEMENTATION OF THE CODEThe following questions and answers address the company’s implementation of the Code. The company has attempted to design procedures that ensuremaximum confidentiality, anonymity, and, most importantly, freedom from the fear of retaliation for complying with and reporting violations under the Code. Inaddition, each associate shall sign the Associate’s Agreement to Comply with the Code in substantially the form attached as Appendix A hereto.Q: Who is responsible for administering, updating and enforcing the Code?A: The company’s Board of Directors has appointed a Corporate Compliance Officer and a Compliance Committee that includes the Corporate Compliance Officerand at least one additional member to administer, update and enforce the Code. Ultimately, the Board of Directors of the company must ensure that the CorporateCompliance Officer and the Compliance Committee fulfill their responsibilities.The Corporate Compliance Officer has overall responsibility for overseeing the implementation of the Code. Specific responsibilities of the position areto: • Develop the Code based on legal requirements, regulations and ethical considerations that are raised in the company’s operations; 2 • Ensure that the Code is distributed to all associates and that all associates acknowledge the principles of the Code; • Work with the company’s Audit Committee to provide a reporting mechanism so that associates have a confidential and anonymous method ofreporting not only suspected violations of the Code but concerns regarding federal securities or antifraud laws, accounting issues, or any federal lawrelating to fraud against shareholders; • Implement a training program to ensure that associates are aware of and understand the Code; • Audit and assess compliance with the Code; • Serve as a point person for reporting violations and asking questions under the Code; and • Revise and update the Code as necessary to respond to detected violations and changes in the law.The Compliance Committee is comprised of the Corporate Compliance Officer, the Chief Executive Officer and the Vice President, Finance and ChiefFinancial Officer. The primary responsibilities of the Compliance Committee are to: • Assist the Corporate Compliance Officer in developing and updating the Code; • Develop internal procedures to monitor and audit compliance with the Code; • Serve as point persons for reporting violations and asking questions under the Code; • Set up a mechanism for anonymous reporting of suspected violations of the Code by associates and refer, when appropriate, such reports to theAudit Committee; • Conduct internal investigations, with the assistance of counsel, of suspected compliance violations; • Evaluate disciplinary action for associates who violate the Code; • In the case of more severe violations of the Code, make recommendations regarding disciplinary action to the Board of Directors or a committeethereof; and • Evaluate the effectiveness of the Code and improve the Code.The Compliance Committee will provide a summary of all matters considered under the Code to the Board of Directors or a committee thereof at eachregular meeting thereof, or sooner if warranted by the severity of the matter. All proceedings and the identity of the person reporting will be kept confidential to theextent required by applicable law.Q: How can I contact the Corporate Compliance Officer and the Compliance Committee?A: The names and phone numbers of the Corporate Compliance Officer and each member of the Compliance Committee are listed below. Any one of theseindividuals can assist you in answering questions or reporting violations or suspected violations under the Code. Michael I. HalsteadCorporate Compliance Officer (212) 923-3344Sharon Mates, Ph.D.Compliance Committee Member (212) 923-3344Lawrence J. HinelineCompliance Committee Member (410) 832-7585 3The members of the Compliance Committee may change from time to time. You are encouraged to consult the copy of the Code that is included on the company’swebsite to obtain the most current membership of the Compliance Committee. III.GENERAL REQUIREMENTSEach associate of the company is expected to be honest, fair, and accountable in all business dealings and obligations, and to ensure: • the ethical handling of conflicts of interest between personal and professional relationships; • full, fair, accurate, timely and understandable disclosure in the reports required to be filed by the company with the Securities and ExchangeCommission and in other public communications made by the company; and • compliance with applicable governmental laws, rules and regulations. IV.CONFLICTS OF INTERESTAssociates should avoid any situation that may involve, or even appear to involve, a conflict between their personal interests and the interests of thecompany. In dealings with current or potential customers, suppliers, contractors, and competitors, each associate should act in the best interests of the company tothe exclusion of personal advantage. Immediate family members of associates, executive officers and directors are also covered in certain circumstances. Forpurposes of this section, a “significant” amount or interest shall be deemed to be any amount in excess of $50,000 and an “immediate family member” in respect ofany person means any child, stepchild, parent, stepparent, spouse, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law of such person, and any person (other than a tenant or employee) sharing the household of such person.Associates and, in certain circumstances, their immediate family members, are prohibited from any of the following activities which could represent anactual or perceived conflict of interest: • No associate or immediate family member of an associate shall have a significant financial interest in, or obligation to, any outside enterprise whichdoes or seeks to do business with the company or which is an actual or potential competitor of the company, without prior approval of theCompliance Committee, or in the case of executive officers or members of the Board of Directors, the full Board of Directors 4 or a committee thereof; provided however, that this provision shall not prevent any associate from investing in any mutual fund or owning up to1% of the outstanding stock of any publicly traded company. • No associate shall conduct a significant amount of business on the company’s behalf with an outside enterprise which does or seeks to do businesswith the company if an immediate family member of the associate is a principal or officer of such enterprise, or an employee of such enterprisewho will play a significant role in the business done or to be done between the company and such enterprise, without prior approval of theCompliance Committee, or in the case of executive officers or members of the Board of Directors, the full Board of Directors or a committeethereof. • No executive officer or employee, or an immediate family member of an executive officer or an employee, shall serve as a director, officer or inany other management or consulting capacity of any actual competitor of the company. • No director, or an immediate family member of a director, shall serve as a director, officer or in any other management or consulting capacity ofany actual competitor of the company, without the prior approval of the full Board of Directors or a committee thereof. • No associate shall use any company property or information or his or her position at the company for his or her personal gain. • No associate shall engage in activities that are directly competitive with those in which the company is engaged. • No associate shall divert a business opportunity from the company to such individual’s own benefit. If an associate becomes aware of anopportunity to acquire or profit from a business opportunity or investment in which the company is or may become involved or in which thecompany may have an existing interest, the associate should disclose the relevant facts to the Corporate Compliance Officer or a member of theCompliance Committee. The associate may proceed to take advantage of such opportunity only if the company is unwilling or unable to takeadvantage of such opportunity as notified in writing by the Compliance Committee. • No associate or immediate family member of an associate shall receive any loan or advance from the company, or be the beneficiary of a guaranteeby the company of a loan or advance from a third party, except for customary advances or corporate credit in the ordinary course of business orapproved by the Compliance Committee. Please see Section V.E. below, “Corporate Advances”, for more information on permitted corporateadvances.In addition, the Audit Committee of the Board of Directors will review and approve, in advance, all related-person transactions, as required by theSecurities and Exchange Commission, The Nasdaq Stock Market or any other regulatory body to which the company is subject. 5Each associate should make prompt and full disclosure in writing to the Corporate Compliance Officer or a member of the Compliance Committee of anysituation that may involve a conflict of interest. Failure to disclose any actual or perceived conflict of interest is a violation of the Code. V.PROTECTION AND PROPER USE OF COMPANY ASSETSProper protection and use of company assets and assets entrusted to it by others, including proprietary information, is a fundamental responsibility of eachassociate of the company. Associates must comply with security programs to safeguard such assets against unauthorized use or removal, as well as against loss bycriminal act or breach of trust. The provisions hereof relating to protection of the company’s property also apply to property of others entrusted to it (includingproprietary and confidential information).A. Proper Use of Company PropertyThe removal from the company’s facilities of the company’s property is prohibited, unless authorized by the company. This applies to furnishings,equipment, and supplies, as well as property created or obtained by the company for its exclusive use – such as client lists, files, personnel information, referencematerials and reports, computer software, data processing programs and data bases. Neither originals nor copies of these materials may be removed from thecompany’s premises or used for purposes other than the company’s business without prior written authorization from the Compliance Committee.The company’s products and services are its property; contributions made by any associate to their development and implementation are the company’sproperty and remain the company’s property even if the individual’s employment or directorship terminates.Each associate has an obligation to use the time for which he or she receives compensation from the company productively. Work hours should bedevoted to activities directly related to the company’s business.B. Confidential InformationThe company provides its associates with confidential information relating to the company and its business with the understanding that such informationis to be held in confidence and not communicated to anyone who is not authorized to see it, except as may be required by law. The types of information that eachassociate must safeguard include (but are not limited to) the company’s plans and business strategy, unannounced products and/or contracts, sales data, significantprojects, customer and supplier lists, patents, patent applications, trade secrets, manufacturing techniques and sensitive financial information, whether in electronicor paper format. These are costly, valuable resources developed for the exclusive benefit of the company. No associate shall disclose the company’s confidentialinformation to an unauthorized third party or use the company’s confidential information for his or her own personal benefit. 6C. Accurate Records and ReportingUnder law, the company is required to keep books, records and accounts that accurately and fairly reflect all transactions, dispositions of assets and otherevents that are the subject of specific regulatory record keeping requirements, including generally accepted accounting principles and other applicable rules,regulations and criteria for preparing financial statements and for preparing periodic reports filed with the Securities and Exchange Commission. All companyreports, accounting records, sales reports, expense accounts, invoices, purchase orders, and other documents must accurately and clearly represent the relevant factsand the true nature of transactions. Reports and other documents should state all material facts of a transaction and not omit any information that would be relevantin interpreting such report or document. Under no circumstance may there be any unrecorded liability or fund of the company, regardless of the purposes for whichthe liability or fund may have been intended, or any improper or inaccurate entry knowingly made on the books or records of the company. No payment on behalfof the company may be approved or made with the intention, understanding or awareness that any part of the payment is to be used for any purpose other than thatdescribed by the documentation supporting the payment. In addition, intentional accounting misclassifications (e.g., expense versus capital) and improperacceleration or deferral of expenses or revenues are unacceptable reporting practices that are expressly prohibited.The company has developed and maintains a system of internal controls to provide reasonable assurance that transactions are executed in accordance withmanagement’s authorization, are properly recorded and posted, and are in compliance with regulatory requirements. The system of internal controls within thecompany includes written policies and procedures, budgetary controls, supervisory review and monitoring, and various other checks and balances, and safeguards,such as password protection to access certain computer systems.The company has also developed and maintains a set of disclosure controls and procedures to ensure that all of the information required to be disclosedby the company in the reports that it files or submits under the Securities Exchange Act is recorded, processed, summarized and reported within the time periodsspecified by the Securities and Exchange Commission’s rules and forms.Associates are expected to be familiar with, and to adhere strictly to, these internal controls and disclosure controls and procedures.Responsibility for compliance with these internal controls and disclosure controls and procedures rests not solely with the company’s accountingpersonnel, but with all associates involved in approving transactions, supplying documentation for transactions, and recording, processing, summarizing andreporting of transactions and other information required by periodic reports filed with the Securities and Exchange Commission. Because the integrity of thecompany’s external reports to shareholders and the Securities and Exchange Commission depends on the integrity of the company’s internal reports andrecord-keeping, all associates must adhere to the highest standards of care with respect to our internal records and reporting. The company is committedto full, fair, accurate, timely, and understandable disclosure in the periodic reports required to be filed by it with the Securities and ExchangeCommission, and it expects each associate to work diligently towards that goal. 7Any associate who believes the company’s books and records are not in accord with these requirements should immediately report the matter to theHotline, the Corporate Compliance Officer or a member of the Compliance Committee. The company has adopted explicit anti-retaliation policies with respect tothese matters, as described in Section I above.D. Document RetentionNumerous federal and state statutes require the proper retention of many categories of records and documents that are commonly maintained bycompanies. In consideration of those legal requirements and the company’s business needs, all associates must maintain records in accordance with these laws and,if any, the company’s document retention policy.Any record, in paper or electronic format, relevant to a threatened, anticipated or actual internal or external inquiry, investigation, matter or lawsuit maynot be discarded, concealed, falsified, altered, or otherwise made unavailable, once an associate has become aware of the existence of such threatened, anticipatedor actual internal or external inquiry, investigation, matter or lawsuit.When in doubt regarding retention of any record, an associate must not discard or alter the record in question and should seek guidance from theCorporate Compliance Officer or a member of the Compliance Committee. Associates should also direct all questions regarding document retention and relatedprocedures to the Corporate Compliance Officer or a member of the Compliance Committee. In addition, from time to time, the company may adopt additionalspecific written policies and procedures with respect to document retention or amend its existing policies and procedures. All associates will be notified if suchpolicies and procedures are adopted or if existing policies and procedures are amended.E. Corporate AdvancesUnder law, the company may not loan money to associates except in limited circumstances. It shall be a violation of the Code for any associate toadvance company funds to any other associate or to himself or herself except for usual and customary business advances for legitimate corporate purposes whichare approved by a supervisor or pursuant to a corporate credit card for usual and customary, legitimate business purposes. It is the company’s policy that anyadvance to an associate over $5,000 be approved in advance by the Compliance Committee.Company credit cards are to be used only for authorized, legitimate business purposes. An associate will be responsible for any unauthorized charges to acompany credit card. 8VI.FAIR DEALING WITH CUSTOMERS, SUPPLIERS, COMPETITORS, AND ASSOCIATESThe company does not seek to gain any advantage through the improper use of favors or other inducements. Good judgment and moderation must beexercised to avoid misinterpretation and adverse effect on the reputation of the company or its associates. Offering, giving, soliciting or receiving any form of bribeto or from an employee of a customer or supplier to influence that employee’s conduct is strictly prohibited.A. Giving GiftsCash or cash-equivalent gifts must not be given by an associate to any person or enterprise. Gifts, favors and entertainment may be given to non-governmental employees if what is given: • is consistent with customary business practice; • is not excessive in value and cannot be construed as a bribe or pay-off; • is not in violation of applicable law or ethical standards; and • will not embarrass the company or the associate if publicly disclosed.See also subsection E below for considerations relating to gifts to foreign officials and Section VII.B below for considerations relating to gifts togovernment employees.B. Receiving GiftsGifts, favors, entertainment or other inducements may not be accepted by associates or members of their immediate families from any person ororganization that does or seeks to do business with, or is a competitor of, the company, except as common courtesies usually associated with customary businesspractices. If the gift is of more than token value, the Compliance Committee must approve its acceptance.An especially strict standard applies when suppliers are involved. If a gift unduly influences or makes an associate feel obligated to “pay back”the other party with business, receipt of the gift is unacceptable.It is never acceptable to accept a gift in cash or cash equivalent. Even cash gifts of token value must be declined and returned to the sender.C. Unfair CompetitionAlthough the free enterprise system is based upon competition, rules have been imposed stating what can and what cannot be done in a competitiveenvironment. The following practices can lead to liability for “unfair competition” and should be avoided. They are violations of the Code.Disparagement of Competitors. It is not illegal to point out weaknesses in a competitor’s service, product or operation; however, associates maynot spread false rumors 9about competitors or make misrepresentations about their businesses. For example, an associate may not pass on anecdotal or unverified stories about acompetitor’s products or services as the absolute truth (e.g., the statement that “our competitors’ diagnostic testing procedures have poor quality control”).Disrupting a Competitor’s Business. This includes bribing a competitor’s employees, posing as prospective customers or using deceptive practicessuch as enticing away employees in order to obtain secrets or destroy a competitor’s organization. For example, it is not a valid form of “market research” to visit acompetitor’s place of business posing as a customer.Misrepresentations of Price and Product . Lies or misrepresentations about the nature, quality or character of the company’s services and productsare both illegal and contrary to company policy. An associate may only describe our services and products based on their documented specifications, not based onanecdote or his or her belief that our specifications are too conservative.D. Antitrust ConcernsFederal and state antitrust laws are intended to preserve the free enterprise system by ensuring that competition is the primary regulator of the economy.Every corporate decision that involves customers, competitors, and business planning with respect to output, sales and pricing raises antitrust issues. Compliancewith the antitrust laws is in the public interest, in the interest of the business community at large, and in our company’s interest.Failing to recognize antitrust risk is costly. Antitrust litigation can be very expensive and time-consuming. Moreover, violations of the antitrust laws can,among other things, subject you and the company to the imposition of injunctions, treble damages, and heavy fines. Criminal penalties may also be imposed, andindividual associates can receive heavy fines or even be imprisoned. For this reason, antitrust compliance should be taken seriously at all levels within thecompany.A primary focus of antitrust laws is on dealings between competitors. In all interactions with actual or potential competitors all associates must followthese rules: • Never agree with a competitor or a group of competitors to charge the same prices or to use the same pricing methods, to allocate services,customers, private or governmental payor contracts or territories among yourselves, to boycott or refuse to do business with a provider, vendor,payor or any other third party, or to refrain from the sale or marketing of, or limit the supply of, particular products or services. • Never discuss past, present, or future prices, pricing policies, bundling, discounts or allowances, royalties, terms or conditions of sale, costs, choiceof customers, territorial markets, production quotas, allocation of customers or territories, or bidding on a job with a competitor. 10 • Be careful of your conduct. An “agreement” that violates the antitrust laws may be not only a written or oral agreement, but also a “gentlemen’sagreement” or a tacit understanding. Such an “agreement” need not be in writing. It can be inferred from conduct, discussions or communicationsof any sort with a representative of a competitor. • Make every output- and sales-related decision (pricing, volume, etc.) independently, in light of costs and market conditions and competitive prices. • Carefully monitor trade association activity. These forums frequently create an opportunity for competitors to engage in antitrust violations.Another focus of antitrust law is how a company deals with customers, suppliers, contractors and other third parties. The following practices could raiseissues, and associates should always consult with the Corporate Compliance Officer or the Compliance Committee before doing any of the following: • Refuse to sell to any customers or prospective customer; • Enter into any new distribution or supply agreement which differs in any respect from those previously approved; • Condition a sale on the customer’s purchasing another product or service, or on not purchasing the product of a competitor; • Agree with a customer on a minimum or maximum resale price of our products; • Impose restrictions on the geographic area to which our customers may resell our products; • Require a supplier to purchase products from the company as a condition of purchasing products from that supplier; • Enter into an exclusive dealing arrangement with a supplier or customer; or • Offer different prices, terms, services or allowances to different customers who compete or whose customers compete in the distribution ofcommodities.If our company has a dominant or potentially dominant position with respect to a particular product or market, especially rigorous standards of conductmust be followed. In these circumstances, all associates should: • Consult with the Corporate Compliance Officer or the Compliance Committee before selling at unreasonably low prices or engaging in anybundling practices; and 11 • Keep the Corporate Compliance Officer or the Compliance Committee fully informed of competitive strategies and conditions in any areas wherethe company may have a significant market position.Finally, always immediately inform the Corporate Compliance Officer or the Compliance Committee if local, state or federal law enforcement officialsrequest information from the company concerning its operations.E. Unfair Practices in International BusinessUnder the Foreign Corrupt Practices Act (“FCPA”), associates of the company are prohibited from making certain gifts to foreign officials. “Foreignofficials” include not only persons acting in an official capacity on behalf of a foreign government, agency, department or instrumentality, but also representativesof international organizations, foreign political parties and candidates for foreign public office. The gift is “corrupt” under the FCPA if it is made for the purposeof: • influencing any act or decision of a foreign official in his official capacity; • inducing a foreign official to do or omit to do any act in violation of his lawful duty; • inducing a foreign official to use his position to affect any decision of the government; or • inducing a foreign official to secure any “improper advantage.”A gift is still “corrupt” even when paid through an intermediary. Any associate who has any questions whatsoever as to whether a particular gift might be“corrupt” under the FCPA, please contact the Corporate Compliance Officer or any member of the Compliance Committee. 12VII.GOVERNMENT RELATIONSAssociates must adhere to the highest standards of ethical conduct in all relationships with government employees and must not improperly attempt toinfluence the actions of any public official.A. Government Procurement and FundingThe U.S. government, governments of other countries and many state, regional and local governments have adopted comprehensive laws and regulationsgoverning the purchase of products from private contractors or the provision of funds to the private sector for research and development. These laws andregulations are intended to assure that governmental entities receive pricing, terms, and/or conditions equivalent to those granted to the company’s most favoredcommercial counterparties and that there is full and open competition in contracting.When selling products or services to, or seeking funding from, government agencies, the company is accountable for complying with all applicable laws,regulations, and requirements. Certifications to, and contracts with, government agencies are to be signed by a company associate authorized by the Board ofDirectors to sign such documents, based upon knowledge that all requirements have been fully satisfied.B. Payments to OfficialsPayments or gifts shall not be made directly or indirectly to any government official or associate if the gift or payment is illegal under the laws of thecountry having jurisdiction over the transaction, or if it is for the purpose of influencing or inducing the recipient to do, or omit to do, any act in violation of his orher lawful duty. Under no circumstances should gifts be given to any government employees.C. Political ContributionsCompany funds, property or services may not be contributed to any political party or committee, or to any candidate for or holder of any office of anygovernment. This policy does not preclude, where lawful, company expenditures to support or oppose public referendum or separate ballot issues, or, where lawfuland when reviewed and approved in advance by the Compliance Committee, the formation and operation of a political action committee. 13VIII.COMPLIANCE WITH LAWS, RULES AND REGULATIONSA. Insider Trading PolicyThe company expressly forbids any associate from trading on material non-public information or communicating material non-public information toothers in violation of the law. This conduct is frequently referred to as “insider trading.” This policy applies to every associate of the company and extends toactivities both within and outside their duties to the company, including trading for a personal account.The concept of who is an “insider” is broad. It includes officers, directors and employees of a company. In addition, a person can be a “temporary insider”if he or she enters into a special confidential relationship in the conduct of a company’s affairs and as a result is given access to information solely for thecompany’s purpose. A temporary insider can include, among others, a company’s investment advisors, agents, attorneys, accountants and lending institutions, aswell as the employees of such organizations. An associate may also become a temporary insider of another company with which our company has a contractual orother relationship.Trading on inside information is not a basis for liability unless the information is material. This is information that a reasonable investor would considerimportant in making his or her investment decisions, or information that is likely to have a significant effect on the price of a company’s securities.Information is non-public until it has been effectively communicated to the marketplace. Tangible evidence of such dissemination is the best indicationthat the information is public. For example, information found in a report filed with the Securities and Exchange Commission or appearing in a national newspaperwould be considered public.Each associate should be familiar with and abide by the company’s Insider Trading Policy. A copy of this policy is given to all new associates of thecompany and is available from the Corporate Compliance Officer or any member of the Compliance Committee.B. Equal Employment OpportunityThe company makes employment-related decisions without regard to a person’s race, color, religious creed, age, sex, sexual orientation, marital status,national origin, ancestry, present or past history of mental disorder, mental retardation, learning disability or physical disability, including, but not limited to,blindness and genetic predisposition, or any other factor unrelated to a person’s ability to perform the person’s job. “Employment decisions” generally meandecisions relating to hiring, recruiting, training, promotions and compensation, but the term may encompass other employment actions as well.The company encourages its associates to bring any problem, complaint or concern regarding any alleged employment discrimination to the attention ofthe Corporate Compliance Officer. Associates who have concerns regarding conduct they believe is discriminatory should also feel free to make any such reports tothe Corporate Compliance Officer, a member of the Compliance Committee, or the Hotline. 14C. Sexual Harassment PolicyThe company is committed to maintaining a collegial work environment in which all individuals are treated with respect and dignity and which is free ofsexual harassment. In keeping with this commitment, the company will not tolerate sexual harassment of associates by anyone, including any supervisor, co-worker, vendor, client or customer, whether in the workplace, at assignments outside the workplace, at company-sponsored social functions or elsewhere.Each associate should be familiar with and abide by the company’s Sexual Harassment Policy. A copy of this policy is given to all associates of thecompany and is available from the Corporate Compliance Officer or any member of the Compliance Committee.D. Health, Safety & Environment LawsHealth, safety, and environmental responsibilities are fundamental to the company’s values. Associates are responsible for ensuring that the companycomplies with all provisions of the health, safety, and environmental laws of the United States and of other countries where the company does business.The penalties that can be imposed against the company and its associates for failure to comply with health, safety, and environmental laws can besubstantial, and include imprisonment and fines.E. Health Care RegulationsThe company is committed to full compliance with federal and state laws, including laws prohibiting health care fraud and abuse such as the federal andstate anti-kickback laws, the physician self-referral law commonly known as the Stark law and the federal and state false claims laws.The federal anti-kickback statute prohibits the knowing and willful payment of remuneration to a physician, hospital or other source with the intent toinduce the physician, hospital or other source to refer patients or order or recommend any items or services paid for by any federal health care program. There arecertain “safe harbor” exceptions to this statute; however, their application is very complicated. A violation of the federal anti-kickback statute can result in severepenalties, including criminal conviction, fines and exclusion from Medicare and Medicaid programs. Many other jurisdictions, including many states, have similaranti-kickback laws governing items or services payable under government programs and/or by private insurance companies.A federal statute similar to the federal anti-kickback statute is the Stark Law. The Stark Law prohibits physicians who have certain financial relationshipswith health care entities from ordering designated health services for their patients from such entities. Certain safe harbor provisions exist, but are complicated intheir application. A violation of the Stark Law can result in denial of payment and civil monetary penalties. 15Federal and state false claims laws prohibit knowing and willful false statements or representations made in connection with a claim submitted forreimbursement to health care programs such as Medicare and Medicaid. Claims that (i) provide misleading or incomplete information to customers regarding healthcare products or services, (ii) fail to include proper documentation or show a failure to obtain proper diagnosis information and (iii) bill for services not rendered,coded improperly or otherwise not rendered in the manner required, have resulted in penalties to providers under false claims statues. A violation of a false claimsstatute can result in severe consequences including civil penalties and criminal conviction.As the application of federal and state anti-kickback and false claims laws is very complicated and nuanced, it is imperative that an associate withquestions about the application of these laws contact the Corporate Compliance Officer or a member of the Compliance Committee for guidance in advance oftaking any action. IX.QUESTIONS UNDER THE CODE AND WAIVER PROCEDURESAssociates are encouraged to consult with the Corporate Compliance Officer and Compliance Committee about any uncertainty or questions they mayhave under the Code.If any situation should arise where a course of action would likely result in a violation of the Code but for which the associate thinks that a valid reasonfor the course of action exists, the associate should contact the Corporate Compliance Officer or a member of the Compliance Committee to obtain a waiver prior tothe time the action is taken. No waivers will be granted after the fact for actions already taken. Except as noted below, the Compliance Committee will review allthe facts surrounding the proposed course of action and will determine whether a waiver from any policy in the Code should be granted.Waiver Procedures for Executive Officers and Directors. Waiver requests by an executive officer or member of the Board of Directors shall be referredby the Compliance Committee, with its recommendation, to the Board of Directors or a committee thereof for consideration. If either (i) a majority of theindependent directors on the Board of Directors, or (ii) a committee comprised solely of independent directors agrees that the waiver should be granted, it will begranted. The company will disclose the nature and reasons for the waiver on a Form 8-K to be filed with the Securities and Exchange Commission within fourbusiness days or as otherwise permitted by the rules of the Securities and Exchange Commission and The Nasdaq Stock Market. If the Board denies the request fora waiver, the waiver will not be granted and the associate may not pursue the intended course of action.It is the company’s policy only to grant waivers from the Code in limited and extraordinary circumstances. 16X.FREQUENTLY ASKED QUESTIONS AND ANSWERS (FAQ’S) REGARDING REPORTING VIOLATIONS UNDER THE CODE,WHISTLEBLOWER POLICY AND HOTLINEThe following questions and answers address each associate’s obligation to comply with the Code. The company has attempted to design procedures thatensure maximum confidentiality and, most importantly, freedom from the fear of retaliation for complying with and reporting violations under the Code.Q: Do I have a duty to report violations under the Code?A: Yes, participation in the Code and its compliance program is mandatory. You must immediately report any suspected or actual violation of the Code tothe Hotline, the Corporate Compliance Officer or a member of the Compliance Committee. The company will keep reports confidential to the fullest extentrequired by applicable law. Failure to report suspected or actual violations is itself a violation of the Code and may subject you to disciplinary action, up to andincluding termination of employment or legal action.Q: I’m afraid of being fired for raising questions or reporting violations under the Code. Will I be risking my job if I do?A: The Code contains a clear anti-retaliation pledge, meaning that if you in good faith report a violation of the Code by the company, or its agents actingon behalf of the company, to the Hotline, the Corporate Compliance Officer or another member of the Compliance Committee, the company will undertake toprotect you from being fired, demoted, reprimanded or otherwise harmed for reporting the violation, even if the violation involves you, your supervisor, or seniormanagement of the company. Note, however, that while you will not be disciplined for reporting a violation, you may be subject to discipline with respect to theunderlying conduct or violation. You are entitled to make the report on a confidential and anonymous basis. To the extent an investigation must be initiated, thecompany will keep confidential any report you make to the Corporate Compliance Officer or another member of the Compliance Committee to the extent requiredby applicable law.In addition, if you in good faith report a suspected violation under the Code which you reasonably believe constitutes a violation of a federal statute bythe company, or its agents acting on behalf of the company, to a federal regulatory or law enforcement agency, you may not be reprimanded, discharged, demoted,suspended, threatened, harassed or in any manner discriminated against in the terms and conditions of your employment for reporting the suspected violation,regardless of whether the suspected violation involves you, your supervisor or senior management of the company.Associates are encouraged to pursue all internal reporting channels through completion and reasonably await and consider the results of all internalinvestigations prior to reporting matters outside of the company. We have instituted the procedures described in this Code, including procedures to makeanonymous submissions (a form of internal report), to facilitate the use of internal investigations. 17Individuals should also consider leaving, but are not required to leave, their name or a contact number when submitting a report. Such information mayfacilitate a more thorough and efficient investigation. The Corporate Compliance Officer will strive to maintain the integrity and confidentiality of all compliance-related communications. However, in certain circumstances, the identity of the person reporting the issue may become known or may need to be revealed,particularly if federal or state enforcement authorities become involved in the investigation. The company cannot guarantee confidentiality when material evidenceof a violation of the law is disclosed or if the person is identified during the normal course of an investigation.Q: How are suspected violations investigated under the Code?A: When a suspected violation is reported to the Hotline, the Corporate Compliance Officer or a member of the Compliance Committee, the ComplianceCommittee will gather information about the allegation by interviewing the associate reporting the suspected violation, the associate who is accused of the violationand/or any co-workers or associates of the accused associates to determine if a factual basis for the allegation exists. The reporting associate’s immediate supervisorwill not be involved in the investigation if the reported violation involved that supervisor. The company will keep the identity of the reporting associate confidentialto the fullest extent required by applicable law.If the report is not substantiated, the reporting associate will be informed and at that time will be asked for any additional information not previouslycommunicated. If there is no additional information, the Corporate Compliance Officer will close the matter as unsubstantiated.If the allegation is substantiated, the Compliance Committee will make a judgment as to the degree of severity of the violation and the appropriatedisciplinary response. In more severe cases, the Compliance Committee will make a recommendation to the Board of Directors of the company for its approval.The Board’s decision as to disciplinary and corrective action will be final. In the case of less severe violations, the Corporate Compliance Officer may refer theviolation to the individual’s supervisor for appropriate disciplinary action.The Compliance Committee shall provide a summary of all matters considered under the Code to the Board of Directors or a committee thereof at eachregular meeting thereof, or sooner if warranted by the severity of the matter.Q: Do I have to participate in any investigation under the Code?A: Your full cooperation with any pending investigation under the Code is a condition of your continued relationship with the company. The refusal tocooperate fully with any investigation is a violation of the Code and grounds for discipline, up to and including termination. 18Q: What are the consequences of violating the Code?A: As explained above, associates who violate the Code may be subject to discipline, up to and including termination of employment. Associates whoviolate the Code may simultaneously violate federal, state, local or foreign laws, regulations or policies. Such associates may be subject to prosecution,imprisonment and fines, and may be required to make reimbursement to the company, the government or any other person for losses resulting from the violation.They may be subject to punitive or treble damages depending on the severity of the violation and applicable law.Q: What if I have questions under the Code or want to obtain a waiver under any provision of the Code?A: The Corporate Compliance Officer and any member of the Compliance Committee can help answer questions you may have under the Code.Particularly difficult questions will be answered with input from the Compliance Committee as a whole. In addition, Section IX of the Code provides informationon how you may obtain a waiver from the Code; waivers will be granted only in very limited circumstances. You should never pursue a course of action that isunclear under the Code without first consulting the Corporate Compliance Officer or the Compliance Committee, and if necessary, obtaining a waiver from theCode. 19APPENDIX AASSOCIATE’S AGREEMENT TO COMPLYI have read the Intra-Cellular Therapies, Inc. Corporate Code of Conduct and Ethics (the “Code”). I have obtained an interpretation of any provision aboutwhich I had a question. I agree to abide by the provisions of the Code. Based on my review, I acknowledge that To the best of my knowledge, I am not in violation of, or aware of any violation by others of, any provision contained in the Code; OR I have made a full disclosure on the reverse side of this acknowledgement of the facts regarding any possible violation of theprovisions set forth in the Code.In addition, I understand that I am required to report any suspected or actual violation of the Code, and that I may make such reports on a fullyanonymous basis through the mechanisms described in this Code. I understand that I am required to cooperate fully with the company in connection with theinvestigation of any suspected violation. I understand that my failure to comply with the Code or its procedures may result in disciplinary action, up to andincluding termination. By: Date: Name (Please print): Department/Location: 20Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the following Registration Statements:(1) Registration Statement (Form S-8 No. 333-205070) pertaining to the Intra-Cellular Therapies, Inc. Amended and Restated 2013 Equity Incentive Plan of Intra-Cellular Therapies, Inc.,(2) Registration Statement (Form S-3 No. 333-204509) of Intra-Cellular Therapies, Inc.,(3) Registration Statement (Post-Effective Amendment No. 3 to Form S-1 on Form S-3 No. 333-191238) of Intra-Cellular Therapies, Inc., and(4) Registration Statement (Form S-8 No. 333-193310) pertaining to the ITI, Inc. 2003 Equity Incentive Plan, as amended, and the Intra-Cellular Therapies, Inc.2013 Equity Incentive Plan of Intra-Cellular Therapies, Inc.;of our reports dated February 25, 2016, with respect to the consolidated financial statements of Intra-Cellular Therapies, Inc. and the effectiveness of internalcontrol over financial reporting of Intra-Cellular Therapies, Inc. included in this Annual Report (Form 10-K) of Intra-Cellular Therapies, Inc. for the year endedDecember 31, 2015./s/ Ernst & Young LLPBaltimore, MDFebruary 25, 2016Exhibit 31.1CERTIFICATIONS UNDER SECTION 302I, Sharon Mates, Ph.D., certify that:1. I have reviewed this annual report on Form 10-K of Intra-Cellular Therapies, Inc.;2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for theregistrant and have:a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure thatmaterial information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during theperiod in which this report is being prepared;b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, toprovide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles;c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of thedisclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andd) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’sinternal control over financial reporting; and5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely toadversely affect the registrant’s ability to record, process, summarize and report financial information; andb) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting.Date: February 25, 2016 /s/ Sharon Mates, Ph.D.Sharon Mates, Ph.D.Chairman, President and Chief Executive Officer(principal executive officer)Exhibit 31.2CERTIFICATIONS UNDER SECTION 302I, Lawrence J. Hineline, certify that:1. I have reviewed this annual report on Form 10-K of Intra-Cellular Therapies, Inc.;2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for theregistrant and have:a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure thatmaterial information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during theperiod in which this report is being prepared;b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, toprovide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles;c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of thedisclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andd) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’sinternal control over financial reporting; and5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely toadversely affect the registrant’s ability to record, process, summarize and report financial information; andb) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting.Date: February 25, 2016 /s/ Lawrence J. HinelineLawrence J. HinelineVice President of Finance and Chief Financial Officer(principal financial officer and principal accounting officer)Exhibit 32.1CERTIFICATIONS UNDER SECTION 906Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of theundersigned officers of Intra-Cellular Therapies, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:The Annual Report for the year ended December 31, 2015 (the “Form 10-K”) of the Company fully complies with the requirements of Section 13(a) or 15(d)of the Securities Exchange Act of 1934, and the information contained in the Form 10-K fairly presents, in all material respects, the financial condition and resultsof operations of the Company. Dated: February 25, 2016 /s/ Sharon Mates, Ph.D. Sharon Mates, Ph.D. Chairman, President and Chief Executive Officer(principal executive officer)Dated: February 25, 2016 /s/ Lawrence J. Hineline Lawrence J. Hineline Vice President of Finance and Chief Financial Officer(principal financial officer and principal accounting officer)

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