Intra-Cellular Therapies Inc.

Good morning, ladies and gentlemen, and welcome to Intracellular Therapy's second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. A slide deck that you may find helpful while you listen to this call is available on the investor relations section of the company's website. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press Start 11 again. Please be advised that today's conference is being recorded. I would now like to turn the call over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Sir, you may begin.

Good morning, and thank you all for joining us on our second quarter 2024 earnings call. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Newman, Chief Commercial Officer, Dr. Suresh Durgaon, Chief Medical Officer, and Larry Heinlein, Chief Financial Officer. 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 statements 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 reliance on these forward-looking statements. These statements are made only as of the date of this conference call, and the company disclaims any obligations to update such statements. I will now turn the call over to Sharon.

Thanks, Juan. Good morning, and thank you for joining us today. We are pleased to report our strong progress in Q2. In addition to Keplida's impressive growth trajectory, during the quarter we announced robust positive results from our two phase three clinical trials in major depressive disorder, or MDD. These results form the basis for an expanded label for Keplida, and we are on track to submit a supplemental MDA for Keplida for the adjunctive treatment of MDD later this year. In addition, we continue to advance our broad development pipeline, which I will discuss later. We are very pleased with the company's progress. Our vision has been to establish Keplida as a first choice treatment across multiple depressive disorders, and we are well on our way to achieving this goal. Keplida has already become an important treatment option for schizophrenia and bipolar depression, and we now have generated strong efficacy data and favorable safety and tolerability data in our phase three studies in MDD. Pending FDA approval, we are confident in Keplitis potential to become a leading medication for the treatment of MDD and a commercial success in this large market. This confidence is bolstered by our proven commercial capabilities and our strong financial position. Before discussing progress with our pipeline, let me list highlights of our second quarter financial performance. In the second quarter, Keplighta net product sales increased to $161.3 million, representing a 46% growth versus the same period in 2023. The uptake of Keplighta remains strong, and we look forward to continued growth. Consequently, we are increasing our Kaplida net product sales guidance range for the full year 2024 to $650 to $680 million. As we continue to maximize Kaplida's opportunity in bipolar depression, we plan to expand our reach in primary care during this quarter. Mark and Larry will provide further details on our expansion plans during their remarks. I would now like to further discuss our adjunctive MDD program. Last quarter, we announced robust positive top line results from studies 501 and 502. These studies evaluated rumeteperone 42 milligrams as an adjunctive treatment to antidepressants in patients with MDD. We are particularly proud to have two global phase three studies with robust and consistent positive results. Both studies demonstrated robust efficacy of Lumotepirone added to an antidepressant for the treatment of MDD in the primary endpoint, the Madras total score with a large separation versus placebo of 4.9 points in study 501 and 4.5 points in study 502. And a robust effect size of 0.61 in study 501 and 0.56 in study 502. In both studies, symptom improvement occurred as early as one week. Both studies also met the key secondary endpoint, CGIS, and showed statistically significant efficacy in the patient's self-reported measure of symptom severity of depression, or the QID score. The favorable safety and tolerability profile for lumatepolone in these studies was consistent with our other capillitis studies. We previously described the metabolic profile of Lumetepirone in Study 501. We are now pleased to share the Lumetepirone metabolic profile in Study 502. Similar to Study 501, mean changes in key metabolic parameters, including glucose, insulin, triglycerides, and total cholesterol, including LDL and HDL cholesterol, were similar between Lumetepirone and placebo. Importantly, mean changes in weight were also similar to placebo. Our team is currently preparing our supplemental NDA submission, which we expect to file with the FDA later this year. We look forward to sharing additional results from study 501 and 502 with the medical community this fall at upcoming conferences, including ACNT and PsychCongress. The opportunity for Capilita and MVD is sizable. Current antidepressant therapies do not adequately address depressive symptoms in more than half of patients receiving treatment. We believe these patients deserve new treatment options. Depression now represents about 30% of all antipsychotic prescriptions in the U.S., similar to the percentage of antipsychotic prescriptions generated for bipolar disorder. We are very excited about the possibility of bringing teplida to patients with MDD and believe its efficacy, tolerability, and safety profile, coupled with its convenient dosing, have the potential to make it a first choice for adjunctive treatment of MDD. We continue to invest in ometepirone's development with the objective of helping a greater number of patients. To that end, our pediatric program is underway. This pediatric program includes an open-label safety study in schizophrenia and bipolar disorder, a double-blind placebo-controlled study in bipolar depression, and two double-blind placebo-controlled studies in irritability associated with autism spectrum disorder. Currently, pediatric patients have limited treatment options. There are only two antipsychotics approved for the treatment of irritability associated with autism spectrum disorder, and two antipsychotics approved for the treatment of bipolar depression in the pediatric population. These treatments are associated with treatment-limiting side effects. Given the characteristics of this patient population and Keplita's favorable profile, we believe Keplita may play an important role for this patient population. In addition, we have initiated two phase three studies evaluating rumetepirone for the acute treatment of manic or mixed episodes associated with bipolar I disorder, commonly known as bipolar mania. Our adult bipolar mania program is the result of an agreement with the FDA in connection with our Lumetapiron pediatric exclusivity program. This agreement provides that pharmacokinetic studies in adolescents and children, together with bipolar mania studies in adults, would be sufficient to satisfy our obligations with respect to obtaining pediatric exclusivity. Completing the overview of our Lumateparone programs, we continue to advance our long-acting injectable Lumateparone program and expect to initiate phase one studies with several formulations shortly. I also want to share updates on other candidates in our pipeline. ITI1284 represents the most advanced product candidate in our pipeline. I am pleased to point out that we recently initiated patient enrollment in our Phase II clinical trial evaluating ITI1284 for generalized anxiety disorder, or GAD, as adjunctive therapy to generalized anxiety medications. We also initiated patient enrollment in our Phase II clinical study evaluating 1284 as monotherapy for psychosis associated with Alzheimer's disease. We also anticipate commencing patient enrollment in our phase two program with 1284 for agitation in Alzheimer's disease shortly. These studies are large and designed as potential registration studies. In our GAD study, we expect to enroll approximately 705 patients randomized to three arms, placebo and two doses of 1284. The primary endpoint of the study is the improvement of anxiety symptoms versus placebo at week six, as measured by the Hamilton Anxiety Rating Scale, or HAM-A. The key secondary endpoint is the CGIS. We expect to initiate a second GAD study evaluating ITI1284 as monotherapy later this year. In our Alzheimer's disease psychosis study, we expect to enroll approximately 370 patients randomized to two arms, placebo and a flexible dose of ITI-1284. The primary endpoint is to evaluate the efficacy of ITI-1284 versus placebo as measured by change from baseline to the end of week six in the behavioral pathology in Alzheimer's disease rating scale, or BEHAVE-AD. psychosis subscale score. The key secondary endpoint is the CGIS. Continuing with our pipeline, next year we expect to report top line results from our ongoing phase two study with lenmisipodin in Parkinson's disease. The primary endpoint of the study relates to motor symptom improvements, and we are also exploring the effects of lenmisipodin in cognition, a key non-motor manifestation of the disease and measuring biomarkers of neuroinflammation to help inform next steps. ITI1020, our second PDE1 inhibitor, is being developed for oncology indications and continues in a phase one single ascending dose study in healthy volunteers. Regarding ITI333, our multiple ascending dose study and a positron emission tomography study are both ongoing. ITI 1549 continues to advance in preclinical development, and we expect to begin clinical testing in 2025. ITI 1549 is a non-hallucinogenic psychedelic, which we now refer to as a neuroplastogen, that we believe lacks hallucinogenic and cardiovascular side effects associated with psychedelics. Certain neuropsychiatric diseases, including MDD and anxiety, are associated with loss of synaptic connectivity, primarily in prefrontal cortical regions of the brain. These drugs have the potential to restore lost functional activity. Therefore, ITI 1549 has the potential to be a safe, effective medicine with a novel mechanism of action that can be safely and conveniently administered to patients for the treatment of these disorders. In summary, we are thrilled with our second quarter results and progress with our pipeline. We are in a strong financial position, ending the second quarter with approximately $1.025 billion in cash, cash equivalents, and investment securities, and we have no debt. Lastly, we are excited to welcome Sanjeev Narula as our Chief Financial Officer later this month. Sanjeev is a finance leader with extensive experience in the pharmaceutical industry, and I look forward to working with him as we continue to build on ITCI's success. You can read more about Sanjeev's background in the press release we issued earlier this morning. I also want to thank Larry for his significant contributions and wish him all the best in his well-deserved retirement. I'll now turn the call over to Mark to provide details on Kaplita's performance and our expansion plans. Mark?