Intra-Cellular Therapies Inc.

Good morning, and welcome to Intracellular Therapy's second quarter financial results conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please, go ahead.

Good morning, and thank you all for being here. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Newman, Chief Commercial Officer, Dr. Suresh Dorgan, Chief Medical Officer, and Larry Heinlein, Chief Financial Officer. As a reminder, during today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations. These are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission including our quarterly and annual reports. Your caution not to place any reliance on these forward-looking statements, and the company disclaims any obligation to update such statements. I will now turn the call over to Sharon.

Thanks, Juan. Good morning, everyone, and welcome to today's conference call. Today, I'm pleased to share our second quarter results which, consistent with past quarters, continue to demonstrate a high demand for Capilita. In Q2, Capilita total prescriptions increased by 96% compared to second quarter of 2022 and increased 13% sequentially compared to Q1 2023. Second quarter total revenues increased to $110.8 million. Keplida net sales increased to $110.1 million, a 100% growth versus the same period in 2022. Keplida continues to be extremely well received by healthcare providers and patients. In recognition of our robust performance to date and our confidence in continued growth, we are raising our Keplida full year 2023 net product sales guidance range to $445 to $465 million from our previous guidance of $430 to $455 million. Since Keplida's launch, we've built a solid foundation with growth coming from increasing the breadth of our prescriber base as well as increasing the depth of prescribing. This is a reflection of the confidence that prescribers have gained in their real-world use of Keplida and the benefits their patients are experiencing during treatment with Keplida. Mark will further discuss our commercial efforts later on this call and will describe how we will continue to build on Keplida's success. We continue to develop Lumateparone for other disorders and advance the rest of our pipeline. Let's start with Lumateparone's breath of positioning and mood disorders. We are very pleased with the positive reception that our mixed feature study, study 403, has received from leaders in the psychiatry community and equally excited about the drug's potential to help large numbers of patients. As a reminder, in this study, Lumetepirone 42 milligrams was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asperger Depression Rating Scale, or MADDRS, for the combined mixed feature patient population of MDD and bipolar depression and the individual patient populations of MDD with mixed features and bipolar depression with mixed features. The robust effect sizes range from 0.64 to 0.67. Starting in September, we will be presenting results from Study 403 at major psychiatry meetings. We also plan to submit a manuscript describing the 403 results in the second half of this year. We have been analyzing study 403 results and refining our regulatory and commercial strategy. Lastly, we plan to meet with the FDA later this year and discuss this important program with the agency. We continue to analyze study 403 data and today we'd like to share with you an important post hoc analysis we conducted of a pre-specified patient population as this analysis even further strengthens our confidence in caplitis potential as a treatment for MDD and other mood disorders. At entry into the study, we documented the patient population presenting with anxious distress, commonly known as anxious depression, using DSM-5 criteria. Anxious distress is a specifier in the DSM-5 and refers to the concomitant presence of anxiety symptoms during a current episode of depression. Our analysis showed that the antidepressant effects of Lumetepirone in patients with mixed features and anxious distress were robust. In study 403, Lumetepirone significantly improved Madger's total score compared with placebo in the combined MDD and bipolar depression mixed features population with anxious distress with a mean difference versus placebo of 6.1 points, a robust effect size of 0.67 with a p-value of less than 0.0001. Additionally, each patient population of MDD and bipolar depression patients had robust results. We plan to present a detailed analysis of these data at a medical meeting later this year. It is estimated that about 55% of patients with MDD experience anxious distress, and a similar rate is estimated for bipolar depression. The presence of anxious distress is associated with treatment non-response, higher suicide risk, and longer duration of illness. This important analysis showing robust antidepressant effects of Lumotepirone in patients with mixed features and anxious distress as another line of evidence of capillitis potential across the spectrum of mood disorders. In total, we have shown Lumotepirone has antidepressant effects in different patient populations with mood disorders, including those with schizophrenia, with comorbid depression, bipolar depression, mixed features in both MDD and bipolar depression, and now in anxious distress in both MDD and bipolar depression. These patient populations are known to be difficult to treat and are more costly to the healthcare system. Let's now turn to our Lumateparone Adjunctive MDD Clinical Program. We have three ongoing phase three studies study 501, 502, and 505 in our registration program, evaluating rumetepirone as an adjunctive treatment for MDD in patients who partially respond to antidepressants. As has been our practice as we approach completion of clinical studies, we provide guidance on the expected timing of top-line results and filing of our SNDA with the FDA. We are now at this point with the conduct of our first two adjunctive MDD trials. We expect top line results from study 501 in the first quarter of 2024 and results from study 502 in the second quarter in 2024. Subject to the results of these studies, we anticipate filing our SNDA in the second half of 2024. As you can see, we are excited about our adjunctive MDD program. and Keplida's broad potential across mood disorders. Our optimism is based on multiple lines of evidence, including the mechanism of action via the interactions with the dopamine, serotonin, and glutamate systems, and strong clinical evidence supporting the antidepressant effects of Keplida across different patient populations. We also continue to study our Lumotepirone long-acting injectable formulations. We expect to initiate phase 1 single ascending dose studies with several new formulations of our LAI later this year and expect these studies to continue through next year. This is a key step in developing long-acting injectable formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer. Turning to our pipeline, 1284 is an important program for the expansion of our neuropsychiatry franchise. This year, we expect to initiate Phase 2 programs evaluating ITI1284 in generalized anxiety disorder in psychosis in patients with Alzheimer's disease and agitation in patients with Alzheimer's disease. We are committed to building our neuropsychiatric franchise through ongoing R&D efforts. Today, I'm pleased to introduce our new program, ITI1500. This program is focused on development of novel, non-hallucinogenic psychedelics. As you are aware, interest has reemerged in the potential of hallucinogenic psychedelics for the treatment of mood and anxiety disorders. However, adverse effects of these hallucinogenic psychedelics have raised safety issues, including abuse liability, cardiac pathology related to 5-HT, 2B receptor agonism, hallucinations due to 5-HT2A agonism, and persistence of perceptual disorders that may limit broad use. Our chemists have developed novel compounds that allow the safe exploration of the full therapeutic potential of this new drug class. Compounds in this program, which we call the ITI1500 series, interact with the serosenergic 5-HT2A receptors in a unique way. In animal models of neuropsychiatric disorders, these compounds retain the beneficial effects of psychedelics while lacking liabilities of known psychedelics, including hallucinogenic potential and cardiac valvular pathologies. Our lead compound in this program, IPI1549, possesses this desirable pharmacologic profile and is currently being evaluated in IND enabling studies. and expected to enter human testing in late 24 or early 2025. We plan to present data on this program at upcoming scientific conferences, and we look forward to sharing this data with you. We also plan to discuss this program in an upcoming R&D day, which we expect to hold later this year or early next year. Turning to our PDE1 inhibitor platform, patient enrollment is ongoing in our phase two clinical trial of lenris coden, which evaluates improvements in motor symptoms, changes in cognition, and inflammatory biomarkers in patients with Parkinson's disease. For ITI 1020, our cancer immunotherapy candidate, our phase one single ascending dose study is ongoing, evaluating the pharmacokinetic safety and tolerability of different doses in healthy volunteers. Lastly, we also have ongoing studies of for the treatment of opioid use disorder and pain. We have completed the single ascending dose study and we are presently engaged in the multiple ascending dose study and in the PET study looking at receptor occupancy. We look forward to sharing the results of the single ascending dose study later this year and the multiple ascending dose study in 2024. The company is in a strong financial position, ending the second quarter with approximately $515 million in cash, cash equivalents and investment securities and no debt. We're very proud of our performance, which has enabled us to serve patients and expand our development programs. We are pleased to be delivering transformative care to patients with neuropsychiatric conditions. We look forward to continuing to share our progress with you. I will now turn the call over to Mark to share additional details on Capilita's performance this quarter. Mark?