ITCI Intra-Cellular Therapies Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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Lumateperone ITI-007-402
Bipolar depression
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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ITI-214-105
Heart failure
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Phase 1/2
Phase 1/2
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Phase 1/2 top-line data released June 29, 2020 noted improved cardiac output by increasing heart contractility and decreasing vascular resistance.
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ITI-007 - Monotherapy (Study 404)
Bipolar depression
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Phase 3
Phase 3
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Phase 3 trial met primary endpoint - July 8, 2019.
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Lumateperone ITI-007-403
Bipolar Depression
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Phase 3
Phase 3
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Phase 3 trial has been initiated - noted March 2, 2020.
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ITI-007 - Monotherapy (Study 401)
Bipolar depression
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Phase 3
Phase 3
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Phase 3 trial did not meet primary endpoint - July 8, 2019.
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Lumateperone
Schizophrenia
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Approved
Approved
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FDA Approval announced December 23, 2019.
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ITI-007-201
Agitation in patients with dementia
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Phase 3
Phase 3
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Phase 3 interim analysis December 18, 2018 noted trial to stop due to futility.
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Latest News
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Study demonstrated inhibiting phosphodiesterase-1 with ITI-214 in patients with heart failure improved cardiac function by enhancing cardiac contractility and dilating systemic arteries without inducing abnormal heart rhythms.
NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) today announced topline results from Study ITI-214-104, a Phase I/II translational study of single ascending doses of ITI-214, a novel, selective phosphodiesterase-1 (PDE1) inhibitor, in patients with chronic systolic heart failure with reduced ejection fraction (HFrEF). ITI-214 is the first PDE1 inhibitor to be tested in patients with HFrEF.
In this study, ITI-214 improved cardiac output by increasing heart contractility and decreasing vascular resistance. Agents that both increase heart contractility (inotropism) and decrease vascular resistance (vasodilation) are called inodilators. Inodilators in current clinical use are associated with the development of arrhythmias, which are abnormal heart rhythms that when serious can impair heart function and lead to mortality. ITI-214, which acts through a novel mechanism of action, was not associated with arrhythmias in this study and was generally well tolerated in all patients.
The results of Study ITI-214-104 are consistent with our prior findings in preclinical models of heart failure and indicate that single-dose administration of ITI-214 can improve heart function in patients with HFrEF. These findings warrant further investigation of acute and chronic PDE-1 inhibition with ITI-214 in this patient population.
"ITI-214 improved the strength of heart contraction on top of lowering blood pressure stress on the heart. This occurred without impacting arrhythmia in patients with heart failure. These exciting results support a novel mechanism of action, and suggest that inhibition of the PDE-1 enzyme concurrent with standard-of-care may benefit heart failure patients without incurring the risks associated with inodilators in current clinical use," said David Kass, M.D., the Abraham and Virginia Weiss Professor of Cardiology at Johns Hopkins University School of Medicine, who was involved in the study.
"Based on these findings, ITI-214 has the potential to be a safe, once-a-day oral inodilator with a novel mechanism of action that could have utility in clinical situations where there is great unmet medical need, ranging from the treatment of acute heart failure to the maintenance of patients with stable chronic HFrEF," said Sharon Mates, Ph.D., Chairman and CEO of Intra-Cellular Therapies, Inc.
The initiation of Study ITI-214-104 followed findings in preclinical models that ITI-214 had improved cardiac output through a mechanism of action different from those of available heart failure therapies. These findings in preclinical models of heart failure were published by researchers at Johns Hopkins University and Intra-Cellular Therapies scientists in the journal Circulation1. Currently available heart failure drugs that strengthen heart contractions, such as PDE3 inhibitors (amrinone and milrinone) and ß-adrenergic agonists (dobutamine), are associated with potentially dangerous complications, such as arrhythmias. ITI-214 does not interact with the ß-adrenergic signaling pathway and does not stimulate abnormal rhythms in an animal model of heart failure. These experimental results demonstrated that ITI-214 may exert its effects via distinct pathways, one of which involves adenosine A2B receptor signaling, and suggest that ITI-214 may represent a mechanistically novel and potentially safe approach for the treatment of human heart failure.
About Study ITI-214-104
Study ITI-214-104 was a randomized, double-blind, placebo-controlled study of escalating single oral doses of ITI-214 (10, 30, and 90 mg) in patients with HFrEF NYHA class II-III. The primary objective of the study was to determine the effects of ITI-214 on cardiac function, using echocardiography with Doppler imaging, in patients with reduced ejection fraction (≤35%) who were already maintained on standard-of-care treatment. Safety was evaluated by monitoring for hemodynamic effects and changes in cardiac rhythm.
Thirty-five patients were enrolled in this study, 9 in each of three dose cohorts and 8 in the placebo arm. The mean age of the patients was 54; 57% were male, and 57% were black. The etiology of the heart failure was ischemic heart disease in 31% of the patients. The mean left ventricular ejection fraction at screening was 25%.
In this study, compared to placebo, single doses of ITI-214 increased mean left ventricular (LV) power index and cardiac output while systemic vascular resistance and mean arterial blood pressure decreased. Reported adverse events were all mild to moderate and consisted of three occurrences of orthostatic hypotension and three episodes of non-postural hypotension. Patients were monitored by continuous telemetry, and no changes in heart rhythms were noted. No serious adverse events were reported. Further details of these results will be presented at upcoming medical conferences.
About Heart Failure
According to the U.S. Centers for Disease Control and Prevention, heart failure affects about 6.5 million adults in the United States and contributes to an estimated one in eight deaths. Heart failure is a chronic condition marked by weakening of the heart muscle that leads to shortness of breath and general body weakness that worsens with physical exertion. There is no cure for heart failure, and there is significant unmet need, particularly for safe agents that can both increase the strength of the heart as well as reduce vascular afterload.Currently available heart failure drugs that can improve the contractile strength of the heart muscle, such as the PDE3 inhibitors amrinone and milrinone, and the β-adrenergic agonist dobutamine, increase cyclic AMP and thereby increase intracellular calcium in cardiac muscle cells. Both approaches are associated with safety risks, most notably arrhythmia.
PDE1 inhibition also modifies cyclic AMP, but it does so in a different manner linked with a novel intracellular pathway that involves adenosine A2B receptor signaling but not ß-adrenergic signaling to stimulate heart contractility. ITI-214 did not cause calcium levels to rise in cardiomyocyte cells. In all of the studies to date, activation of the PDE1-regulated pathway has not triggered arrhythmia.
About ITI-214
ITI-214 is a potent and selective phosphodiesterase type 1 (PDE1) inhibitor. ITI-214 is the lead compound in the Company's PDE1 portfolio and is in development for the treatment of symptoms associated with Parkinson's disease and for the treatment of heart failure. ITI-214 has been generally well tolerated with a favorable safety profile in six Phase 1 clinical trials. ITI-214 works by slowing the breakdown of cyclic nucleotides (cAMP, cGMP), thus allowing these molecules to build up in the cells and to exert important functions. The PDE1 enzyme is highly active in pathological or disease states, and our PDE1 molecules are designed to reestablish normal function in these disease states through the inhibition of the PDE1 enzyme.
In heart disease, excessive PDE1 activity may limit the beneficial effects of cAMP or cGMP, so inhibitors like ITI-214 have the potential to act as a therapy. ITI-214 is an inodilator that can improve cardiac function by both increasing the force of heart contractions and reducing the resistance to pushing blood through the vascular system. Preclinical research has shown that ITI-214 increases cardiac contractility and decreases vascular resistance without increasing abnormal heart rhythms, and the clinical results announced herein indicate that similar, potentially therapeutic physiologic effects can be attained in heart failure patients. ITI-214 is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF).
Previous studies have described the mechanism of action of ITI-214 in the brain. The mechanism of action of ITI-214 and our other PDE1 inhibitors suggests therapeutic potential across a variety of diseases including neurological and cardiovascular diseases.
1. Bui AL, et al. Nat Rev Cardiol. 2011;8: 30-41. 2. Hashimoto et al., Circulation 138:1974-1987 (2018)
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the therapeutic value, clinical and non-clinical development plans and commercial potential of our drug product candidates; the progress, timing and results of our clinical trials and preclinical studies; our beliefs about the extent to which the results of our clinical trials and preclinical studies to date support new drug application filings for product candidates; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of our drug product candidates; the potential for ITI-214 to represent a novel approach for the treatment of human heart failure; that ITI-214 offers a potential new treatment for heart failure with a novel mechanism of action that may provide an effective and safer alternative to existing therapies and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: our current and planned clinical trials, other studies for our product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.
CONTACT:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006
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NEW YORK, May 14, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 2020 RBC Capital Markets Global Healthcare Conference. The presentation is scheduled for Tuesday, May 19, 2020 at 9:10 am ET.
The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
Contact
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130Source: Intra-Cellular Therapies Inc.
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NEW YORK, May 13, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") virtually due to the public health impact of the coronavirus (COVID-19) pandemic and to prioritize the health and well-being of meeting participants.
The Annual Meeting will be held in a virtual-only format on May 27, 2020, at 10:00 a.m., Eastern Time. Stockholders will not be able to attend the Annual Meeting in person, however, stockholders of record and registered beneficial owners as of the close of business on April 6, 2020, will be able to vote and ask questions during the meeting through the online platform.
Attending the Virtual Annual Meeting
Stockholders can attend the meeting by accessing www.meetingcenter.io/238568156 and entering the 15-digit control number found on their proxy card, voting instruction form, notice of internet availability of proxy materials, or email previously received. Stockholders may vote during the Annual Meeting by following the instructions available on the meeting website during the meeting.
A support line will be available on the meeting website shortly prior to, and during, the Annual Meeting to assist stockholders with any technical difficulties they may have accessing or hearing the virtual meeting.
Participating, Voting Electronically and Submitting Questions at the Virtual Annual Meeting
Stockholders of Record
Stockholders of record will be able to participate in the Annual Meeting, vote electronically and submit questions during the live webcast of the meeting, without advance registration. The two items of information needed to access the live webcast of the meeting are the following:
Computershare Control Number: the 15-digit control number found on your proxy card, voting instruction form, notice of internet availability of proxy materials, or email you previously received
Meeting password: ITCI2020
Beneficial Owners
If you are a beneficial owner and hold your shares through an intermediary, such as a bank, broker or nominee, you must register in advance to participate in the Annual Meeting, vote electronically and submit questions during the live webcast of the meeting. To register in advance you must obtain a legal proxy from the bank, broker or other nominee that holds your shares giving you the right to vote the shares. You must forward a copy of the legal proxy along with your email address to Computershare Trust Company, N.A. ("Computershare").
Requests for registration should be directed to Computershare by email at [email protected] no later than 10:00 a.m. Eastern Time, on Tuesday, May 26, 2020. You will receive a confirmation of your registration and instructions on how to attend the meeting by email after Computershare receives your registration materials.
Stockholders may also submit questions in advance of the Annual Meeting by emailing your question, along with proof of ownership, to [email protected]. The Company will, subject to time constraints, answer all questions that are pertinent to the business of the Annual Meeting.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows it to understand how therapies affect the inner-workings of cells in the body. The Company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.Contact
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130 -
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NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the first quarter ended March 31, 2020, and provided a corporate update.
"In the midst of these unprecedented times we are proud of the agile adaptation of our organization to successfully execute a virtual launch of CAPLYTA, a new treatment option for adult patients suffering from schizophrenia," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "Beyond our commercial efforts, we also continue to make progress in the advancement of our development programs, having completed patient enrollment in our Phase 3 clinical trial evaluating lumateperone as an adjunctive treatment in bipolar depression (Study 402) and clinical conduct in our proof-of-mechanism (Phase I/II) study evaluating ITI-214 in patients with heart failure."
CORPORATE UPDATE
COMMERCIAL HIGHLIGHTS
- Successful Launch of CAPLYTA
- Comprehensive promotional activities for CAPLYTA commenced the week of March 30, 2020, following U.S. Food and Drug Administration (FDA) approval of CAPLYTA for the treatment of schizophrenia in adults in December 2019. The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. In pooled data from short term studies, mean changes from baseline in weight, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was similar to placebo.
- Successful completion of a 100% virtual national launch meeting, after onboarding our neuroscience sales specialists that were hired in the first quarter of 2020. The vast majority of our specialists have prior psychiatry medication sales experience, including antipsychotics. After successful completion of our virtual national launch meeting, our neuroscience sales specialists are now actively engaging healthcare providers with the goal of providing comprehensive education on CAPLYTA. Our sales specialists are equipped with remote product presentation and sampling capability. These activities are being complemented by virtual peer-to peer medical education and expanded digital outreach programs.
- Substantial progress in our market access coverage determinations with payers and we are pleased with the coverage achieved to date.
- Introducing LYTAlink™: In support of patient access and affordability we have also introduced LYTAlink™, a comprehensive patient support program designed to provide a number of access and affordability offerings to eligible CAPLYTA patients. The program offerings consist of coverage and reimbursement services, out-of-pocket copay support for commercially insured patients, medication compliance communications, and patient assistance relief specifically for eligible patients without insurance.
- Manufacturing and supply chain related activities are in place and are supporting commercial demand for CAPLYTA. We have substantial product supply in the U.S. with long expiry dating to support expected demand.
- Comprehensive promotional activities for CAPLYTA commenced the week of March 30, 2020, following U.S. Food and Drug Administration (FDA) approval of CAPLYTA for the treatment of schizophrenia in adults in December 2019. The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. In pooled data from short term studies, mean changes from baseline in weight, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was similar to placebo.
CLINICAL HIGHLIGHTS
- Lumateperone in Bipolar Depression: We have completed patient enrollment in Study 402, our Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression, and anticipate reporting topline results from this study in mid-2020.
- ITI-214 in Heart Failure: Clinical conduct in our Phase 1/2 clinical trial of ITI-214, our phosphodiesterase 1 (PDE1) inhibitor, in patients with chronic systolic heart failure has been completed. This study evaluates the hemodynamic profile and safety of single ascending doses of ITI-214. We anticipate reporting topline results from this trial in the second quarter of 2020.
- Other Clinical Programs: We are continuing necessary activities to advance our other development programs and to ensure patient safety in accordance with recent FDA guidelines for clinical trial conduct in the COVID-19 pandemic environment. These programs include our lumateperone clinical program in major depressive disorder, our long-acting injectable program of lumateperone, our ITI-214 program in Parkinson's disease and the initiation of early stage clinical studies for ITI-333, our novel, oral modulator of mu opioid and serotonin receptors for the treatment of opioid and other substance use disorders, pain, and mood disorders. We will provide additional updates on our clinical programs as the current environment evolves.
Selected First Quarter 2020 Financial Results
The Company recorded net product sales of CAPLYTA for the first quarter of 2020 of approximately $882,500. No net product sales were reported for the comparable period of 2019.The Company reported a net loss of $47.4 million, or $0.73 per share (basic and diluted), for the first quarter of 2020 compared to a net loss of $34.8 million, or $0.63 per share (basic and diluted), for the first quarter of 2019.
Research and development (R&D) expenses for the first quarter of 2020 were $16.0 million, compared to $25.0 million for the first quarter of 2019. The $9.0 million decrease is primarily due to lower clinical and non-clinical related costs for lumateperone, manufacturing costs, and is partially offset by higher non-lumateperone related project costs and higher labor costs in the first quarter of 2020.
Selling, general and administrative (SG&A) expenses were $34.1 million for the first quarter of 2020, compared to $11.7 million for the same period in 2019. The increase of $22.4 million is due to an increase of $15.6 million for selling related costs and an increase of $6.8 million for general and administrative costs. The increase in selling related costs is due primarily to hiring a sales force, resulting in an increase in labor expenses of approximately $9.9 million and commercialization costs of $5.8 million. The increase in general and administrative costs is due primarily to an increase in professional fees of approximately $2.1 million, labor related expenses of $1.5 million, and information technology expenses of $1.5 million.
Cash, cash equivalents, restricted cash and investment securities totaled $450.4 million at March 31, 2020, compared to $224.0 million at December 31, 2019. In January 2020, the Company completed a $295.0 million public offering resulting in net proceeds to the Company of approximately $277.0 million from the sale of 10 million shares of its common stock, after deducting underwriting discounts and commissions and offering expenses paid by the Company.
Conference Call and Webcast Details
The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company's financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company's website at www.intracellulartherapies.com. Please connect to the Company's website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 9278748. Please dial in approximately 10 minutes prior to the call.
CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed 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%).
Please click here to see full Prescribing Information including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day). The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
CAPLYTA is being developed for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our expectations regarding the commercialization of CAPLYTA; the potential impact of the COVID-19 pandemic on the commercialization of CAPLYTA, manufacturing and supply of CAPLYTA and our product candidates, our ongoing and planned clinical trials and development programs, and any other aspects of our business; our goal to provide healthcare providers comprehensive education on CAPLYTA; our plans and the expected timing for the availability and reporting of data from our ongoing Phase 3 trials in bipolar depression; our development plans for our PDE program, including ITI-214 and our expected timing for the availability and reporting of data from our heart failure trial; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.
Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)Three Months Ended March 31, 2020 2019 Revenues Product sales, net $ 882,516 $ — Grant revenue 200,963 — Total revenues 1,083,479 — Operating expenses: Cost of product sales 69,311 — Research and development 16,003,326 24,990,856 Selling, general and administrative 34,096,366 11,704,984 Total operating expenses 50,169,003 36,695,840 Loss from operations (49,085,524 ) (36,695,840 ) Interest income 1,678,203 1,860,077 Loss before provision for income taxes (47,407,321 ) (34,835,763 ) Income tax expense 3,281 — Net loss $ (47,410,602 ) $ (34,835,763 ) Net loss per common share: Basic & Diluted $ (0.73 ) $ (0.63 ) Weighted average number of common shares: Basic & Diluted 65,106,103 55,113,226 (1) The condensed consolidated statements of operations for the quarters ended March 31, 2020 and 2019 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31,
2020December 31,
2019(Unaudited) Assets Current assets: Cash and cash equivalents $ 179,593,032 $ 107,636,849 Investment securities, available-for-sale 269,360,926 116,373,335 Restricted cash 1,400,000 — Accounts receivable, net 1,351,013 — Inventory 1,391,124 — Prepaid expenses and other current assets 7,876,405 6,313,785 Total current assets 460,972,500 230,323,969 Property and equipment, net 2,132,987 2,259,740 Right of use assets, net 18,051,146 18,252,074 Deferred tax asset, net — 264,609 Other assets 86,084 86,084 Total assets $ 481,242,717 $ 251,186,476 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 10,994,082 $ 7,425,024 Accrued and other current liabilities 10,667,765 16,138,909 Lease liabilities, short-term 3,211,234 3,187,435 Accrued employee benefits 6,203,283 9,472,651 Total current liabilities 31,076,364 36,224,019 Lease liabilities 19,718,023 19,955,186 Total liabilities 50,794,387 56,179,205 Stockholders' equity: Common stock, $0.0001 par value: 100,000,000 shares authorized; 66,200,761 and 55,507,497 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively 6,620 5,551 Additional paid-in capital 1,188,095,880 904,971,772 Accumulated deficit (757,508,971 ) (710,098,369 ) Accumulated comprehensive (loss) gain (145,199 ) 128,317 Total stockholders' equity 430,448,330 195,007,271 Total liabilities and stockholders' equity $ 481,242,717 $ 251,186,476 (1) The condensed consolidated balance sheets at March 31, 2020 and December 31, 2019 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. - Successful Launch of CAPLYTA
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NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, May 7, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended March 31, 2020.
To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 9278748.
The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130