11/12/2024

speaker
Operator
Conference Operator

Ladies and gentlemen, thank you for standing by. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Helen Rubenstein, Vice President of Investor Relations. Please go ahead.

speaker
Helen Rubenstein
Vice President, Investor Relations

Good morning, and thank you for joining me more at Therapeutics' third quarter 2024 Financial Results Conference Call. Before we begin, I encourage everyone to go to the Investors and Media section of our website at numorotx.com, where you can find the press release related to today's call. With me today are President and Chief Executive Officer Henry Vosabrook and Chief Financial Officer Josh Pinto. Head of Research and Development Rob Lenz will join us for the Q&A portion of the call. I'd like to point out that we'll be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional details. With that, I'll now turn the call over to Henry.

speaker
Henry Vosabrook
President and Chief Executive Officer

Thanks, Helen. Good morning, everyone, and thank you for joining us for our first-ever quarterly conference call. Brain diseases collectively represent one of the greatest medical challenges of our generation, affecting upwards of 1.5 billion people globally. They are the leading cause of disability with a significant impact on quality of life, not only for patients, but for their caregivers, families, and society at large. We all know somebody affected by brain disease, and at Nomura, our goal is to bring the next generation of medicines forward to alleviate the substantial unmet need. To achieve that goal, we have developed a robust portfolio of seven clinical and preclinical programs all targeting novel mechanisms of action in their respective indications. Importantly, we believe that each of our programs has the potential to reshape the treatment of its target indication, making a significant difference for the patients and families we aim to serve. I'll start with our lead program, Novacoprant, which we are investigating for the treatment of major depressive disorder, or MDD, and other neuropsychiatric conditions. MDD is a leading cause of disability worldwide, affecting more than 280 million people. Yet, it has been more than 30 years since a drug with a novel mechanism of action has been approved to treat it. People living with MDD often experience inadequate treatment responses and or significant tolerability challenges, leading them to discontinue standard of care treatment. In fact, up to 85% of patients either don't receive pharmacological treatment or don't achieve remission with first-line therapy. And approximately 70% of people with MDD experience anhedonia, or the lack of ability to experience pleasure from daily activities, which is not adequately treated by existing agents. We believe Nevacopran has the potential to reshape the treatment of MDD. Nevacopran is a highly selective, novel, once-daily kappa-opioid receptor antagonist that we are developing as a potential monotherapy treatment. The Kappa opioid receptor antagonist approach has been clinically validated in three independent studies. In our Phase II MDD study, Nevacobrand demonstrated efficacy in treating depressive symptoms, including anhedonia, in patients with moderate to severe depression, as well as a favorable safety and tolerability profile with no weight gain, sexual dysfunction, or other adverse events commonly associated with standard of care. It is designed to be easy to use as an oral, once daily, 80 milligram dose without titration. Nevacopran has the potential to make a significant difference in the treatment of MDD and beyond if our development efforts are successful. The COSTAL program includes three replicates, phase three randomized placebo-controlled double-blind studies, COSTAL-1, COSTAL-2, and COSTAL-3, designed to evaluate the efficacy and safety of nevacoprine monotherapy in adult patients with moderate to severe MDD. We are also advancing an open-label extension study, Coastal LT, designed to evaluate the long-term safety of nevacoprine. To support the coastal studies, we are deploying a state-of-the-art approach designed to strengthen probability of success that includes significant enhancements to both study design and operational execution relative to phase 2, which are detailed in our corporate deck. We know that both study design and execution are crucial for successful MDD studies, and we are laser-focused on the COSTAL program. We look forward to top-line data readout from COSTAL 1 around the end of this year and to data from COSTAL 2 and COSTAL 3 in the first half of next year. We are also exploring the potential of Novacobrand as a treatment for bipolar disorder and are pleased to be advancing a Phase II signal-seeking study This study is designed to inform further development of Novacoprand in bipolar II depression, potentially including development in broader bipolar disorder populations, as it is power to show an effect size, albeit not power to show statistical significance. We look forward to sharing results from this study in the second half of 2025. Beyond Novacoprand, we are currently evaluating NMRA511, our vasopressin 1A receptor antagonist, in a Phase 1b signal-seeking study in people with Alzheimer's disease agitation. We look forward to reporting data from that study in the second half of 2025. Additionally, we are continuing to progress our M4 franchise with an IND for a second M4 positive allosteric modulator, or PAM, expected in the first half of 2025. We believe that with our franchise of several M4 PAMs in development, We are well positioned to become a leader in muscarinics, an important new class of medicine. Finally, we are advancing a deep pipeline of additional novel clinical and preclinical opportunities, addressing such conditions as Alzheimer's, agitation, schizophrenia, Parkinson's, and ALS. With these programs, I believe we are well on our way to achieve our mission of redefining the development of novel medicines for brain diseases. With that overview, I'll turn the call over to Josh to review our financials. Josh?

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