Intra-Cellular Therapies Inc.

Good morning, and welcome to Intracellular Therapy's first 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. You will then hear an automated message advising your hand has been raised. To lower your hand, press star 1-1 again. Please be advised that 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 today. 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. Those 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 statement. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place any reliance on these for looking at payments and the company disclaims any obligation to update such payments. I will now turn the call over to Sharon.

Thanks Juan. Good morning everyone and welcome to today's call. Following a strong performance last year, 2023 is off to a great start. During the first quarter, Our team delivered strong growth for Keplida and made important progress on the clinical development front. Just a few weeks ago, we announced robust, positive, top-line results from study 403, evaluating lumotepirone in patients with major depressive disorder, or MDD, exhibiting mixed features, and in patients with bipolar depression, exhibiting mixed features. I will talk more about this in a moment. Let's start with our performance with Keplida in Q1. Demand for Keplida and prescriber adoption has been strong. Total prescriptions increased by 159% compared to first quarter of 2022 and increased 16% sequentially in Q1 2023 compared to Q4 2022. First quarter total revenues increased to $95.3 million Our strong prescription growth drove Caplida net revenues of $94.7 million, a 173% growth versus the same period in 2022. We are very pleased with our performance in Q1 and reiterate our prior guidance for full-year Caplida net sales between $430 and $455 million. We are confident in continued growth and the future potential of Caplida. We continue to receive very positive feedback from both prescribers and patients. Physicians cite Keplita's clinical profile and efficacy for a broad range of patients with bipolar depression and schizophrenia. Importantly, patients often highlight improvements in their symptoms and Keplita's favorable side effect profile. This positive feedback further reinforces our belief that Keplita is helping to change the lives of patients. On the clinical front, we continue to expand our Keplida development programs and advance our other pipeline programs. Let's start with our most recent news. In March, we announced robust positive top-line results from study 403. These strong results further validate the potential for Lumotepirone to treat a broad spectrum of mood disorders In this study, we evaluated Lumetepirone 42 milligrams as monotherapy for the treatment of major depressive episodes in patients with MDD exhibiting mixed features and in patients with bipolar depression exhibiting mixed features. Lumetepirone demonstrated a statistically significant and clinically meaningful reduction on the Madras total score compared to placebo at week six, the primary endpoint of the study. This result was demonstrated in the combined patient population of major depressive disorder with mixed features and bipolar depression with mixed features. The drug placebo LS mean difference was 5.7 points with a p-value of less than 0.0001 and the effect size was 0.64. The strong results were consistent for the individual patient populations as well. For the MVD patient population with mixed features, the effect size was 0.67. And for the bipolar depression patient population with mixed features, the effect size was 0.64. The p-value for each of these individual populations was less than 0.0001. Lumotepirone 42 milligrams also met the key secondary endpoints by demonstrating a statistically significant and clinically meaningful reduction in the clinician's global impression scale or CGI compared to placebo at week six in all populations evaluated. Consistent with prior trials, Lumetepirone was generally safe and well tolerated. Patients experiencing depressive episodes with mixed features have more severe illness with higher recurrence rates, comorbidities, and rates of suicide and suicidal ideation. In addition, patients with MDD and mixed features respond poorly to antidepressants. These study results provide important data about the efficacy, tolerability, and safety profile of Lumitecheron for these difficult to treat conditions. These results build on the data we reported in our post hoc analysis of study 404 on the subset of patients with bipolar depression exhibiting mixed features. We are pleased to announce that this analysis has just been published in April in the Journal of Clinical Psychiatry. We plan to meet with the FDA later this year to discuss our study results and determine the next steps for the program. Our Lumetepirone program extends across several major neuropsychiatric conditions, including MDD. We have an ongoing registration program evaluating Lumetepirone as adjunctive treatment for major depressive disorder in patients who partially respond to antidepressants. Subject to the results of our ongoing studies, we expect to file an SMDA in 2024. We have continued, we've also continued to invest in our Lumetepirone long-acting injectable program, having completed a phase one study evaluating one formulation and completed preclinical studies evaluating several formulations which can deliver drugs for one month or longer. The goal of this program is to develop formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer. We plan on progressing these formulations this year and next year. Beyond Lumateparone, we continue to make progress with our other pipeline programs, including ITI1284, our phosphodiesterase 1 or PDE1 inhibitors, and ITI triple 3. Consistent with our Lumetepirone program, these innovative pipeline programs focus on therapeutic areas with significant unmet patient needs. Starting with ITI1284, our deuterated form of Lumetepirone. In 2023, we plan to begin phase 2 clinical studies in patients with agitation and Alzheimer's disease patients with psychosis and Alzheimer's disease, and patients with generalized anxiety disorder, all highly prevalent conditions. Our PDE1 inhibitor program patient enrollment has been initiated in our Phase II proof-of-concept study for lenbospodin, which is being developed for the treatment of motor symptoms in patients with Parkinson's disease. Changes in cognitive measures and inflammatory biomarkers will also be assessed. Extensive evidence supports the involvement of neuroinflammation in the development of Parkinson's disease. We have shown that lenrasposin acts to reduce neuroinflammation by directly modulating intracellular signaling pathways in cells in the brain called microglia. A similar pathway may be involved in controlling immune cell function, particularly macrophages in non-CNS tissues, including certain solid tumors. We have an active IND for our newest PDE1 inhibitor, ATI1020, which is being developed as a novel immunotherapy for oncology indications. Clinical conduct has begun in a single ascending dose study in normal healthy volunteers to establish a safe and tolerable range of doses for further study. The potential of the safe and well-tolerated small molecule as part of the treatment armamentarium for cancer indications is an exciting prospect and we look forward to advancing this program. Finally, we continue to develop ITI-333, our 5-HT2A receptor antagonist and new opioid receptor partial agonist for the treatment of opioid use disorder and pain. In Q1, we began clinical conduct in a multiple ascending dose study in healthy volunteers evaluating pharmacokinetic safety and tolerability of the molecule. Our neuroimaging study is ongoing. Our company is in a strong financial position, ending the quarter with $540.5M in cash, cash equivalents, and investment securities. Additionally, we have no debt. As a company, we remain deeply committed to our goal of developing effective and innovative treatments that improve the lives of patients. We continue to take steps forward to achieve this goal. We believe we have significant growth potential in CapLIDA and the rest of our pipeline, and we look forward to continuing our progress. I will now turn the call over to Mark to further discuss CapLIDA's performance and commercial opportunity. Mark?