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Page 1: Corporate Presentation - static.seekingalpha.com

1

Corporate Presentation

September 2020

Page 2: Corporate Presentation - static.seekingalpha.com

Safe Harbor Statement

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This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based on the current estimates and assumptions of the management of Intra-Cellular Therapies, Inc. (the “Company” or “ITCI”) as of the date of this presentation and are subject to uncertainty and changes. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those indicated by such forward-looking statements include, among others, those set forth in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports and other filings with the SEC. All statements contained in this presentation are made only as of the date of this presentation, and the Company undertakes no duty to update this information unless required by law.

Page 3: Corporate Presentation - static.seekingalpha.com

Intra-Cellular Therapies, Inc. (ITCI)

• Founded in 2002

• Based on Nobel Prize-winning science

– ITCI leverages technology from the lab of Nobel Laureate Dr. Paul Greengard to study intracellular signaling

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• Fully integrated biopharmaceutical company

• CAPLYTA™ (lumateperone) approved for the treatment of schizophrenia in adults*

- Demonstrated efficacy and favorable safety profile

• Lumateperone bipolar depression program:

- sNDA submission to FDA planned in late 2020 or early 2021

- Positive results in two Phase 3 studies

- Potential to be Approved for the Broadest Range of Patients with Bipolar Depression

• Robust pipeline with multiple programs

*Please see Important Safety Information, including Boxed Warning for CAPLYTA on slide 7

Page 4: Corporate Presentation - static.seekingalpha.com

Lumateperone: Novel Medicine Across Major Neuropsychiatric Conditions

Schizophrenia

MDD

~1% of population1

(2.4+ million adults in the US)

~2.8% 12-month prevalence2

(~ 6 million adults in the US)

17.3 million patients in the US3

FDA approved

Positive Results in two Phase 3 studies in bipolar depression

sNDA planned for YE 2020/early 2021

Late-stage program to begin late 2020

1.SARDAA https://sardaa.org/resources/about-schizophrenia/. Accessed Sept. 6, 2020 2 National Institute of Mental Health. Bipolar Disorder. https://www.nimh.nih.gov/health/statistics/bipolar-disorder.shtml. Accessed Sept. 6, 20203. National Institute of Mental Health, Major Depression. https://www.nimh.nih.gov/health/statistics/major-depression.shtml. Accessed Sept. 6, 2020

Condition Prevalence Development Status

Bipolar Disorder

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Page 5: Corporate Presentation - static.seekingalpha.com

CAPLYTA™ FDA-ApprovedDemonstrated efficacy

• Statistically significant improvement in PANSS* total score versus placebo in two well-controlled studies

• Start and stay at effective dose with no titration required

In 4-6 week, placebo-controlled trials:

• Weight gain, fasting glucose, total cholesterol, and triglycerides were similar to placebo

• Extrapyramidal symptoms (incl. akathisia) were similar to placebo

• Prolactin levels were similar to placebo

• Most common adverse events: somnolence/sedation and dry mouth

In a 1-year open-label trial:

• Schizophrenia symptoms remained stable

• Mean change in body weight was approximately - 3.2 kg** at Day 350

• Among patients with normal baseline fasting glucose and insulin levels, 91% and 83% respectively remained normal at Day 300

• 93%, 80% and 92% of patients with normal LDL cholesterol, total cholesterol and triglyceride levels, respectively, at baseline remained normal at day 300

5*PANSS=Positive and Negative Syndrome Scale **Standard Deviation was 7.4

Page 6: Corporate Presentation - static.seekingalpha.com

High Rates of Discontinuation and Switching

Patients often cycle through treatment and relapse

OF PATIENTS DISCONTINUE TREATMENT WITHIN 18 MONTHS OF INITIATION1

~74%

Common antipsychotic side effects that can cause poor compliance and discontinuation2

• Weight gain and metabolic disturbances • Movement disorders• Hyperprolactinemia

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1. Lieberman JA, Stroup TS, et al. N Engl J Med. 2005;353(12):1209-12232. Dibonaventura M et al. BMC Psychiatry. 2012;12:20.

Page 7: Corporate Presentation - static.seekingalpha.com

Warnings and Precautions Are Those Common to the Antipsychotic Class

7Please see full Prescribing Information including Boxed Warning at https://www.intracellulartherapies.com/docs/caplyta_pi.pdf

Important Safety InformationBoxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%)

Page 8: Corporate Presentation - static.seekingalpha.com

Commercial Execution

Promotional Activities Began March 30, 2020• ~240 Neuroscience sales specialists conducting both in person and remote healthcare provider interactions

• Promotional mix consists of interactions by sales team with providers, peer to peer speaker programs, virtual medical conference exhibits and product theaters, journal advertising, and digital marketing efforts

• Direct to consumer campaign including television and social media advertising initiated August 2020

Expect Broad Access Across Payer Channels • Formulary coverage already achieved for >95% of covered lives under Medicare Part D and State Medicaid

plans

• Commercial channel progressing well

• Expect to fully establish market access formulary status across all payer channels by year-end

Strong Commercial Execution through Covid-19 Pandemic Has Driven Successful Launch of CAPLYTA

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Page 9: Corporate Presentation - static.seekingalpha.com

Building our

Future

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Page 10: Corporate Presentation - static.seekingalpha.com

Bipolar Depression

Behavioral Disturbances Associated With Dementia, Including AD

Depressive Disorders

LAI Program

Our Pipeline

PDEInhibitors

PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA

ITI-214 – Parkinson’s Disease

ITI-214 for Other Indications

PLATFORM

ITI-333Pain

Substance Use Disorder

Mood Disorders

ITI-214 – Heart Failure

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Lumateperoneand follow-on compounds

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

Page 11: Corporate Presentation - static.seekingalpha.com

Bipolar Disorder Has a High Prevalence in the U.S.

Bipolar Disorder has a 12-month prevalence of 2.8% in US adults1

• Affects ~6 million adults in the U.S.2

− The prevalences of Bipolar I and II are similar3

• Depressive episodes are longer and recur more often than manic/hypomanic episodes

1. National Institute of Mental Health. Bipolar Disorder. https://www.nimh.nih.gov/health/statistics/bipolar-disorder.shtml . Accessed Sept 6, 2020.

2. Depression and Bipolar Support Alliance. https://www.dbsalliance.org/education/bipolar-disorder/bipolar-disorder-statistics/. Accessed Sept 6, 2020.

3. Merikangas KR et al., Arch Gen Psychiatry. 2011 March ; 68(3): 241–251.11

Unmet Needs in Bipolar Depression

• Few approved treatments available for bipolar depression

• Only one treatment approved for Bipolar II patients with depressive episodes

• Safety and tolerability trade-offs limit use of existing agents

Page 12: Corporate Presentation - static.seekingalpha.com

Two Positive Phase 3 trials Support Label Expansion to include the Treatment of Bipolar Depression

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* On July 8, 2019, ITCI reported top-line results from Studies 401 and 404: Study 404 met its primary endpoint of change from baseline at Week 6 on the MADRS total score; in Study 401 neither dose of lumateperone met the primary endpoint of statistical separation from placebo on the MADRS total score.

• Positive Results in Study 404*: evaluated lumateperone as monotherapy in patients with Bipolar I or Bipolar II disorder

• Positive Results in Study 402: evaluated lumateperone as an adjunctive therapy to lithium or valproate in patients with Bipolar I or Bipolar II disorder

• Favorable safety and tolerability profile of lumateperone seen in this program is consistent with previously reported placebo-controlled and open-label studies in patients with schizophrenia

• We plan to submit an sNDA in late 2020 or early 2021 for the treatment of bipolar depression in patients with Bipolar I or II disorder treated as monotherapy or as adjunctive therapy to lithium or valproate

Page 13: Corporate Presentation - static.seekingalpha.com

Study 404: Lumateperone 42 mg Met Primary Endpoint -Change From Baseline to Day 43 in MADRS Total Score

8 22 29 433615

LS M

ean

Ch

ang

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rom

Bas

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-18

-16

-14

-12

-10

-8

-6

-4

-2

Day

****

****

****

***

*

**

Effect Size−0.56

Placebo

Lumateperone 42 mg

* P < .05, ** P < .01, *** P < .001, **** P < .0001 LSMD vs Placebo. MMRM in the ITT population. Effect size calculated as LSMD/pooled estimate of within subject error standard deviation. ITT, intent-to-treat; LS, least squares; LSMD, least squares mean difference; MADRS, Montgomery-Åsberg Depression Rating Scale; MMRM, mixed-effects model for repeated measures. 13

• Lumateperone 42 mg also met key secondary endpoint: the CGI-BP-S Total Score (p<0.001; effect size = 0.46) - CGI component that specifically assesses depression (CGI-BP-S Depression Score; p<0.001; effect size = 0.50)

Page 14: Corporate Presentation - static.seekingalpha.com

Study 404: CAPLYTA (lumateperone) Met Key Secondary Endpoint

14CAPLYTA is FDA approved for the treatment of schizophrenia in adults. The safety and efficacy have not been established for other uses of CAPLYTA

Placebo CAPLYTA 42 mg

2

-1.75

-1.5

-1.25

-1

-0.75

-0.5

-0.25

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Day

CG

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LS

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Effect Size− 0.50

8 15 22 29 36 43

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Effect Size−0.46

* P < .05, ** P < .01, *** P <. 001 LSMD vs Placebo. MMRM in the ITT population. CGI-BP-S, Clinical Global Impression Scale, Bipolar Version – Severity; ITT, intent-to-treat; LS, least squares; LSMD, least squares mean difference; MMRM, mixed-effects model for repeated measures.

Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S)

CGI-BP-S Depression Score

Page 15: Corporate Presentation - static.seekingalpha.com

Study 402: Lumateperone 42 mg Met Primary Endpoint -Change From Baseline to Day 43 in MADRS Total Score

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• Lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206; effect size = 0.27).

- The least squares (LS) mean reduction from baseline for lumateperone 42 mg was 16.9 points, versus 14.5 points for placebo (LS mean difference = 2.4 points).

• Lumateperone 42 mg also met key secondary endpoint: the CGI-BP-S Depression Score (p=0.0082; effect size = 0.31).

• Lumateperone 28 mg showed a trend for a dose-related improvement in symptoms of depression. - Though not formally tested against placebo since it did not separate on the primary endpoint,

lumateperone 28 mg demonstrated a statistically significant improvement versus placebo on the CGI-BP-S.

• Lumateperone demonstrated a favorable safety profile and was generally well-tolerated in the trial. - The most commonly reported adverse events that were observed at a rate greater than or equal

to 5% and at least twice the rate of placebo were somnolence, dizziness, and nausea. - Rates of akathisia, restlessness, extrapyramidal symptoms and changes in weight were similar to

placebo.

Page 16: Corporate Presentation - static.seekingalpha.com

Regulatory Strategy

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* On July 8, 2019, ITCI reported top-line results from Studies 401 and 404: Study 404 met its primary endpoint of change from baseline at Week 6 on the MADRS total score; in Study 401 neither dose of lumateperone met the primary endpoint of statistical separation from placebo on the MADRS total score.

• We plan to submit an sNDA in late 2020 or early 2021 for the treatment of bipolar depression in patients with Bipolar I or II disorder treated as monotherapy or as adjunctive therapy to lithium or valproate

• Lumateperone has the potential to be approved for the broadest range of patients with bipolar depression

Page 17: Corporate Presentation - static.seekingalpha.com

Lumateperone has Potential to be Approved for the Broadest Range of Patients with Bipolar Depression

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Monotherapy Adjunctive (to lithium or valproate)

Bipolar I Bipolar II Bipolar I Bipolar II

Lumateperone* X X X X

QUETIAPINE1 X X

OLANZAPINE/FLUOXETINE2 X

LURASIDONE3 X X

CARIPRAZINE4 X

*CAPLYTA (lumateperone) is FDA approved for the treatment of schizophrenia in adults. The safety and efficacy have not been established for other uses of CAPLYTA

1. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s069lbl.pdf. Accessed Sept 6, 2020. 2. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021520s053lbl.pdf. Accessed Sept 6, 2020. 3. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf. Accessed Sept 6, 2020. 4. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf. Accessed Sept 6, 2020.

Page 18: Corporate Presentation - static.seekingalpha.com

Advancing our Pipeline

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ITI-333 preclinical program for the treatment of substance use disorders, pain and mood disorders

• Oral modulator of mu opioid and serotonin receptors

• Exhibits potent morphine-like analgesia in animal models, may attenuate several morphine-mediated behaviors (e.g., respiratory depression, reduced gastro-intestinal motility)

Our phosphodiesterase 1 (or PDE1) inhibitor program provides opportunities to pursue innovative treatments for multiple diseases

• PDE1 enzymes are highly active across a variety of neurological and non-CNS disease states

• ITI-214, our lead PDE1 inhibitor molecule, is being studied for the treatment of Parkinson’s disease and heart failure

− Phase I/II studies in Parkinson’s disease and heart failure completed

− Our portfolio of PDE1 inhibitors are also being investigated in a variety of therapeutic areas (e.g. infections, cancers, and other disease states)

Page 19: Corporate Presentation - static.seekingalpha.com

Key Financial Metrics

KEY METRICS

Total Cash, Cash Equivalents, Investments, and restricted cash1 $409.2 million

Total Debt1 $0.0 million

Common Shares Outstanding1 66,777,737

Stock Options/Restricted Stock Units Outstanding1 7,925,229

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1. As of June 30, 2020 (unaudited)

Page 20: Corporate Presentation - static.seekingalpha.com

Management Team

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Sharon Mates, PhD Founder, Chairman, President & Chief Executive Officer

Mark Neumann Executive Vice President & Chief Commercial Officer

Andrew Satlin, MD Executive Vice President & Chief Medical Officer

Michael I. Halstead, Esq. Executive Vice President & General Counsel

Larry Hineline Senior Vice President of Finance & Chief Financial Officer

John A. Bardi Senior Vice President, Market Access, Policy and Government Affairs

Robert Davis, PhD Senior Vice President, Chief Scientific Officer

Suresh Durgam, MD Senior Vice President, Late Stage Clinical Development and Medical Affairs

Michael Olchaskey, PharmD

Senior Vice President, Head of Regulatory Affairs

Juan Sanchez, MD Vice President, Corporate Communications and Investor Relations

Karen Sheehy, Esq. Senior Vice President & Chief Compliance Officer

Page 21: Corporate Presentation - static.seekingalpha.com

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