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Altimmune (ALT) 2025 Conference Transcript
2025-06-04 14:57
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 ...
Altimmune(ALT) - 2025 Q1 - Earnings Call Transcript
2025-05-13 13:32
Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024, primarily due to $35 million raised from the ATM facility [22][20] - R&D expenses for Q1 2025 were $15.8 million, down from $21.5 million in the same period of 2024, with $9.2 million specifically related to pemidutide development [22][24] - General and administrative expenses rose to $6 million from $5.3 million in Q1 2024, mainly due to increased non-cash stock compensation [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant progress in the NASH program, including the upcoming readout of the IMPACT Phase 2b MATCH trial [8][12] - The trial enrolled 212 participants with biopsy-confirmed F2F3 NASH, enhancing the study's power [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), with plans for Phase II trials in these areas [9][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [18] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, focusing on NASH, AUD, and ALD [10][19] - The strategic partnership with Hercules Capital for a $100 million credit facility is intended to support the ongoing development of pemidutide [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [8][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected from the IMPACT trial and the initiation of Phase II trials for AUD and ALD [19][24] Other Important Information - The company is preparing for an end-of-Phase II meeting with the FDA in Q4 2025, which will discuss the potential for accelerated approval in F4 cirrhosis [78][79] - The company has a large safety database for pemidutide, which may allow for more efficient trial designs in Phase III [73] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population are similar to other studies, but precise numbers will be presented later [28][29] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30][31] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [36] Question: How important is weight loss in this study? - Weight loss is crucial, as it addresses comorbidities associated with NASH, and the company aims to achieve clinically meaningful weight loss [40][41] Question: What are the expected placebo responses for fibrosis and NASH resolution endpoints? - Management noted that placebo responses have varied historically, but they expect to control the placebo response effectively in their trial [87][88] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes they will be successful in this area [78][79] Question: Can you confirm the cash runway with the Hercules facility? - The facility will provide $15 million upfront, with additional tranches available, potentially extending the cash runway into Q3 2026 [81][82]
Adial Pharmaceuticals Granted End of Phase 2 Meeting from the U.S. Food and Drug Administration
Globenewswire· 2025-05-08 12:30
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].
New Survey Provides Insights into Diagnosis and Treatment Journey for People Living With Alcohol Use Disorder (AUD)
Prnewswire· 2025-04-30 11:00
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]