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Intra-Cellular Therapies Inc. (Nasdaq: ITCI) is a pioneering biopharmaceutical company headquartered at 3960 Broadway, New York, New York, United States. The company is dedicated to developing novel, small-molecule drugs to treat diseases of the central nervous system (CNS), focusing on neuropsychiatric and neurological disorders.
Core Business and Products:
Intra-Cellular Therapies leverages proprietary chemistry platforms to create innovative treatments for complex psychiatric and neurologic conditions. Its flagship product, CAPLYTA® (lumateperone), is approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder. CAPLYTA's efficacy is believed to stem from its dual action on serotonin 5-HT2A receptors and dopamine D2 receptors.
Recent Achievements:
- Q3 2023 Financial Performance: The company reported a significant revenue increase to $126.2 million, a 75% rise from the same period in 2022.
- CAPLYTA Sales Growth: CAPLYTA's net product sales surged by 75% in Q3 2023, reaching $125.8 million, demonstrating strong prescription uptake.
- 2023 Net Product Sales Guidance: The company raised its CAPLYTA net product sales guidance to $460-470 million.
- Positive Study Results: At the American College of Neuropsychopharmacology (ACNP) Annual Meeting, the company presented positive results for CAPLYTA in patients with major depressive disorder (MDD) and bipolar disorder with anxious distress and mixed features.
- Phase 3 Study Success: In April 2024, Intra-Cellular Therapies announced robust positive Phase 3 results from Study 501, evaluating lumateperone as an adjunctive therapy for MDD.
Financial Condition and Outlook:
Intra-Cellular Therapies continues to show strong financial performance. For the full year 2023, the company reported total revenues of $464.4 million, up from $250.3 million in 2022. CAPLYTA's net product sales for 2023 were $462.2 million, an 86% year-over-year growth. The company has provided a 2024 net product sales guidance of $645 to $675 million.
Partnerships and Future Projects:
Intra-Cellular Therapies has strategic partnerships with several leading financial institutions, including J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley, and RBC Capital Markets, to support its growth and financing strategies. The company is also advancing its pipeline, with upcoming CAPLYTA Phase 3 readouts in adjunctive MDD and additional lumateperone development programs.
Commitment to Safety:
Intra-Cellular Therapies emphasizes the safety and tolerability of its products. CAPLYTA has a favorable safety profile, with the most common adverse reactions being somnolence, dizziness, nausea, and dry mouth. The company remains vigilant in monitoring and communicating any potential risks associated with its therapies.
For more detailed information, please visit the company's official website: www.intracellulartherapies.com
Intra-Cellular Therapies (Nasdaq: ITCI) has announced the appointment of Sanjeev Narula as Executive Vice President and Chief Financial Officer, effective August 12, 2024. Narula, who brings extensive experience from his roles at Viatris, Pfizer, American Express, and Xerox India, will succeed Lawrence Hineline, who is retiring but will remain as a consultant to ensure a smooth transition. Dr. Sharon Mates, ITCI's Chairman and CEO, expressed excitement about Narula joining the leadership team as the company continues its rapid growth. Narula's background includes serving as CFO of Viatris and holding various financial leadership positions at Pfizer over 16 years.
Intra-Cellular Therapies (ITCI) reported strong Q2 2024 results, with CAPLYTA net product sales reaching $161.3 million, a 46% increase year-over-year. Total prescriptions for CAPLYTA grew 36% compared to Q2 2023. The company raised its 2024 CAPLYTA sales guidance to $650-$680 million.
ITCI announced positive Phase 3 results for lumateperone as an adjunctive therapy for major depressive disorder (MDD), with an sNDA submission planned for H2 2024. The company also initiated patient enrollment in Phase 2 studies for ITI-1284 in generalized anxiety disorder and Alzheimer's-related psychosis.
Despite strong sales growth, ITCI reported a net loss of $16.2 million for Q2 2024, an improvement from the $42.8 million loss in Q2 2023. The company ended the quarter with a strong cash position of $1.025 billion.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in central nervous system (CNS) disorder treatments, has announced a conference call and webcast for August 7, 2024, at 8:30 a.m. Eastern Time. The event will provide a corporate update and discuss financial results for the quarter ending June 30, 2024.
Participants can join the call via phone by using the provided registration link. The webcast will be accessible through the company's website under the Investor Relations section. Interested parties are advised to log in 5-10 minutes early to complete the registration process and install any necessary software.
Intra-Cellular Therapies announced positive topline results from Study 502, which evaluated lumateperone 42 mg as adjunctive therapy for Major Depressive Disorder (MDD).
The drug achieved significant and clinically meaningful results in primary and key secondary endpoints. Lumateperone 42 mg showed a 4.5-point reduction on the MADRS total score compared to placebo (p<0.0001; ES=0.56) and a significant reduction in the CGI-S score (p<0.0001; ES=0.51).
Statistically significant results were also observed on the QIDS-SR scale (p<0.0001). The safety profile was generally favorable and consistent with prior studies. An sNDA submission is anticipated in the second half of 2024.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company focusing on CNS disorder therapeutics, announced that its CEO, Sharon Mates, Ph.D., will present at the 45th Annual Goldman Sachs Global Healthcare Conference. The presentation is scheduled for June 11, 2024, at 10:00 a.m. ET in Miami, FL. The live and archived webcast will be available under the 'Events & Presentations' section of the company's website. Attendees are advised to log in 5-10 minutes prior to the event to register and install any necessary software.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in treatments for central nervous system (CNS) disorders, announced that its CEO, Sharon Mates, Ph.D., will present at the Jefferies Global Healthcare Conference. This event is scheduled for June 5, 2024, at 11:00 a.m. ET in New York, NY. A live and archived webcast will be available on the company's website under the Investor Relations section. Viewers are advised to log in 5-10 minutes early to register and install necessary software.
Intra-Cellular Therapies (Nasdaq: ITCI) presented data at the American Society of Clinical Psychopharmacology Annual Meeting, held in Miami from May 28-31, 2024. The data focused on CAPLYTA’s efficacy, safety, and tolerability profiles in treating bipolar I and II disorders, and major depressive disorder (MDD) with mixed features. Key presentations included:
Poster W49: Lumateperone for MDD and Bipolar Disorder with Anxious Distress and Mixed Features.
Poster T40: Lumateperone for MDD and Bipolar Depression with Mixed Features: Symptomatic Efficacy.
Poster T41: Lumateperone for Major Depressive Episodes in MDD and Bipolar Disorders.
CAPLYTA is indicated for schizophrenia and depressive episodes associated with bipolar I or II disorder as monotherapy or adjunctive therapy. The safety profile includes risks such as increased mortality in elderly patients with dementia-related psychosis, suicidal thoughts in young patients, and metabolic changes.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will participate in two investor conferences: 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024, and Bank of America Healthcare Conference 2024 on May 16, 2024. The webcasts will be available on the company's website.
Intra-Cellular Therapies reported strong financial results in Q1 2024 with CAPLYTA net product sales of $144.8 million, a 53% increase from the previous year. The company reiterated its 2024 net sales guidance at $645 - $675 million and announced positive Phase 3 results for lumateperone as an adjunctive therapy for major depressive disorder.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will host a conference call and webcast on May 7, 2024, to discuss the financial results for the first quarter of 2024. The company focuses on CNS disorder therapeutics. Participants can register online to join the call and access the webcast through the Investor Relations section on the company's website.
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