Altimmune (ALT) 2025 Conference June 04, 2025 09:55 AM ET Speaker0 Alright. Welcome everyone to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Song, one of the senior analyst covers Mecha Biotech in The US. It's my great pressure to have the fireside chat with our next presenting company, Altimmune, the CEO of the Pennant and CMO, Scott Harris. Welcome, gentlemen. Speaker1 Thank you. Speaker0 Awesome. Yeah. So, we know know lots eyes on the upcoming phase two MeSH data, But befo ...

Core Viewpoint - Adial Pharmaceuticals is progressing towards a Phase 3 clinical trial for its lead drug candidate AD04, aimed at treating Alcohol Use Disorder (AUD), with an important FDA meeting scheduled for July 25, 2025 to discuss the clinical development plan and trial design [2][3]. Company Overview - Adial Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders [4]. - The lead investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist designed for heavy drinking patients with AUD [4]. - AD04 has shown promising results in the ONWARD™ pivotal Phase 3 clinical trial, demonstrating effectiveness in reducing drinking without significant safety concerns [4]. Clinical Development - The FDA has granted Adial an End of Phase 2 meeting to discuss the proposed clinical development plan and seek guidance on the Phase 3 adaptive trial design for AD04 [2]. - The company has confirmed its 505(b)(2) regulatory bridging strategy with the FDA, indicating strong progress in trial design [3]. - The target patient population for AD04 has been reinforced through recent analyses, supporting its potential effectiveness in treating AUD and related conditions [3]. Future Prospects - The company is optimistic about aligning with the FDA on key requirements to advance AD04 and plans to provide a comprehensive update after the July meeting [3]. - AD04 is also believed to have potential applications in treating other addictive disorders, including Opioid Use Disorder, gambling, and obesity [4].

Core Insights - The survey conducted by The Harris Poll on behalf of Alkermes, Inc. reveals that the diagnosis of alcohol use disorder (AUD) is often prompted by negative consequences of alcohol consumption, and treatment can lead to significant positive changes in the lives of individuals with AUD [1][2][4] Group 1: Diagnosis and Treatment Insights - 47% of respondents were diagnosed with AUD following a hospital or emergency room visit due to symptoms or alcohol-related incidents [2] - One-third of respondents indicated personal concern about alcohol use (36%), healthcare provider visits related to symptoms (35%), and encouragement from loved ones (32%) as factors leading to their diagnosis [2] - 79% of respondents reported negative feelings upon diagnosis, including fear (38%), shame (33%), and embarrassment (32%) [2][3] Group 2: Treatment Engagement and Impact - 70% of respondents reported currently being treated for AUD, while 28% had been treated in the past but were not currently receiving treatment [6] - Among those treated, 50% were using prescription medication, 46% were in behavioral therapy, and 43% were involved in support group therapy [6] - Over half of the respondents indicated that treatment positively impacted their physical health (61%), overall quality of life (60%), and relationships with children (60%) [6] Group 3: Role of Healthcare Providers - 33% of respondents were diagnosed by an addiction specialist, and 26% by a primary care physician [6] - 80% of respondents discussed prescription medication for AUD with their healthcare provider, with 50% choosing their medication based on provider recommendations [6] - Only 28% of respondents were diagnosed through routine screenings during standard healthcare visits, highlighting a gap in proactive diagnosis [6]