Reviva Pharmaceuticals Holdings (RVPH) Update / Briefing June 02, 2025 08:00 AM ET Speaker0 As a reminder, this call is being recorded, and a replay will be made available on the Reviva website following the conclusion of the event. I'd now like to turn the call over to doctor Lax Bhatt, founder, president, and chief executive officer of Reviva Pharmaceuticals. Please go ahead, Lax. Speaker1 Thank you, Tara. So good morning, everyone. My name is Lax Bart. I am the founder, president, and CEO of Reviva Pharm ...

Reviva Pharmaceuticals Reviva | Corporate Presentation 3 Phase 3 RECOVER Open-Label Extension (OLE) Trial of Brilaroxazine in Schizophrenia June 2, 2025 at 8:00am EDT Forward-Looking Statements This presentation contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's expectations regarding the anticipate ...

– Robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms – – Generally well-tolerated with low rates of adverse events and discontinuation – – Brilaroxazine improved multiple neuroinflammatory markers reported to enhance efficacy and mitigate side effects – – Virtual investor webcast today at 8:00 a.m. EDT – CUPERTINO, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage p ...

SAN DIEGO, May 28, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of data from the Phase 2 study of NBI-1117568 in adults with schizophrenia, which showed a significant improvement in symptoms and overall severity and highlighted new data on the safety and tolerability of the treatment. NBI-1117568 is the first and only investigational oral muscarinic M4 selective orthosteric agonist in clinical development as a potential treatment for schizophrenia. These ...

Financial Data and Key Metrics Changes - The cash position as of March 31 was $115.8 million with no debt [10] - Cash utilized in operating activities during the quarter was $5.9 million [10] - General and administrative expenses decreased to $2.6 million from $2.9 million year-over-year [11] - Research and development expenses increased slightly to $9.9 million from $9.7 million year-over-year [11] - The net loss for the quarter was reported at $11.2 million or $0.13 per share [11] Business Line Data and Key Metrics Changes - The company continues to focus on noninvasive targeted upstream precision compounds, particularly for Alzheimer's disease and schizophrenia [4] - Blacaramazine for Alzheimer's disease showed significant clinical benefits over three years of treatment [5] - Enrollment in the Phase II clinical study of ANAVEX 371 for schizophrenia was successfully completed with 71 participants [6][7] Market Data and Key Metrics Changes - The company is actively engaging with potential partners for the distribution of blacaramazine in Europe [27] - Discussions with CROs are ongoing to establish a sales force for potential drug launch [27] Company Strategy and Development Direction - The company aims to advance precision medicine compounds with a focus on scalable treatment alternatives for Alzheimer's and schizophrenia [13] - The strategy includes preparing for potential drug launches in various international markets, including Europe, Canada, and Australia [32][34] Management's Comments on Operating Environment and Future Outlook - Management expects feedback from the EMA regarding Alzheimer's treatment submission by the end of the year or early next quarter [15] - The focus remains on the safety and biomarker effects of the schizophrenia trial, addressing significant unmet needs in treatment [17][18] Other Important Information - The company has expanded its scientific advisory board with the appointment of experts in Alzheimer's disease [8] - The advantages of oral blacaramazine include timely access to treatment without logistical barriers, benefiting both patients and caregivers [46][49] Q&A Session Summary Question: Timeline for EMA feedback on Alzheimer's treatment - Management expects feedback by the end of the year or early next quarter, with no interim updates provided [15] Question: Key inflection points for 2025 - The focus is on the Phase II study in schizophrenia, particularly on safety and biomarker effects [17] Question: Details on the schizophrenia trial duration - The trial consists of two parts, with Part B lasting 28 days [23] Question: Pre-launch activities for blacaramazine in Europe - The company is in discussions with potential partners and CROs to ensure readiness for distribution [27] Question: Countries that might piggyback on European approval - Other regions include South America, Africa, the Middle East, and parts of Asia [31] Question: Parallel discussions with regulatory bodies - The company plans to initiate discussions with Canadian and Australian authorities in parallel with European feedback [34] Question: Revenue timeline post-approval - Revenue could potentially be realized in the March quarter, depending on logistical factors [41] Question: Drug manufacturing and launch inventory - The drug is manufactured by a major US manufacturer, and the company has a large launch inventory [42]

Core Insights - Anavex Life Sciences Corp. has successfully completed enrollment for its Phase 2 clinical study of ANAVEX3-71, targeting schizophrenia, with a total of 71 participants [2][3][4] - The study consists of two parts: Part A with 16 participants focusing on multiple ascending doses, and Part B with 55 participants aimed at providing comprehensive clinical and biomarker data [3][4] - Top-line data from the study is expected to be reported in the second half of 2025 [5] Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, and schizophrenia [2][7] - The lead drug candidate, ANAVEX2-73, has shown promise in multiple clinical trials for Alzheimer's disease and other CNS disorders [7][8] - ANAVEX3-71 is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, which may address all symptom domains of schizophrenia without the side effects associated with standard antipsychotics [4][8] Industry Context - Schizophrenia affects nearly 24 million people globally, with significant unmet medical needs due to limitations of current treatments [6] - Approximately 34% of individuals with schizophrenia do not respond to existing therapies, and 50-60% experience only partial improvement or unacceptable side effects [6]

SAN DIEGO, April 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 3 registrational program to evaluate the efficacy, safety and tolerability of NBI-1117568, the company's investigational oral muscarinic M4 selective orthosteric agonist, as a potential treatment for schizophrenia. Positive top-line data for the Phase 2 clinical study in adults with schizophrenia were reported in August 2024."There is a significant need for new and innovative medic ...