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Altimmune to Announce Topline 24 Week Results from its IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH on Thursday, June 26
Globenewswire· 2025-06-25 23:12
Core Viewpoint - Altimmune, Inc. is set to present topline data from its IMPACT Phase 2b trial evaluating pemvidutide for treating metabolic dysfunction-associated steatohepatitis (MASH) on June 26, 2025 [1][2]. Group 1: Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [5]. - The company's lead program, pemvidutide, is a GLP-1/glucagon dual receptor agonist aimed at treating MASH, obesity, Alcohol Use Disorder (AUD), and Alcohol-associated Liver Disease (ALD) [5]. Group 2: IMPACT Study Details - The IMPACT trial enrolled 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at doses of 1.2 mg and 1.8 mg or placebo for 24 weeks [3]. - Key efficacy endpoints include MASH resolution or fibrosis improvement at 24 weeks, with secondary endpoints focusing on weight loss and non-invasive tests [3]. - A total of 48 weeks of treatment is planned, with final readout expected in Q4 2025 [3]. Group 3: Pemvidutide Characteristics - Pemvidutide is an investigational peptide-based dual receptor agonist that mimics the effects of diet and exercise on weight loss, suppressing appetite and increasing energy expenditure [4]. - Clinical trials have shown significant MASH resolution, liver fibrosis improvement, and weight loss, along with reductions in liver fat content, triglycerides, LDL cholesterol, and blood pressure [4]. - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with ongoing trials for AUD and ALD [4].
Altimmune Announces Multiple Presentations at Upcoming American Diabetes Association's Scientific Sessions
Globenewswire· 2025-06-13 11:30
Core Insights - Altimmune, Inc. is presenting findings on pemvidutide, a novel GLP-1/glucagon dual receptor agonist, at the American Diabetes Association's 85 Scientific Sessions, focusing on its potential in treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, alcohol use disorder (AUD), and alcohol-associated liver disease (ALD) [1][4]. Group 1: Presentation Details - The oral presentation titled "Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight" will be held on June 21, 2025, at 5:45 PM CDT [2]. - Three poster presentations will cover topics including cardiovascular safety, non-invasive tests of central adiposity, and cholesterol transport in a hamster model, all scheduled for June 22, 2025 [2]. Group 2: Pemvidutide Overview - Pemvidutide is designed to activate GLP-1 and glucagon receptors, mimicking the effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure [3]. - Clinical trials have shown that pemvidutide leads to significant weight loss, preservation of lean mass, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure [4]. Group 3: Regulatory Status and Trials - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with the MOMENTUM Phase 2 obesity trial completed in 2024 and ongoing IMPACT Phase 2b MASH trial expected to report top line results in Q2 2025 [4]. - IND applications for AUD and ALD have received FDA clearance, with the Phase 2 trial for AUD starting in Q2 2025 and the ALD trial set to begin in Q3 2025 [4]. Group 4: Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases, with pemvidutide as its lead program [5].
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 Vs. Viking Therapeutics: Evaluating Pipeline Maturity, And Takeover Potential
Seeking Alpha· 2025-06-02 14:51
Core Insights - Pfizer has decided to discontinue the development of Danuglipron due to safety concerns and is now looking for business development opportunities to acquire promising product candidates [1] Group 1: Company Actions - Pfizer is actively seeking to acquire new product candidates following the halt of Danuglipron's development [1] Group 2: Analyst Background - The analyst has over 20 years of experience in research and development of novel Cell & Gene Therapies, focusing on assessing the potential of new treatments and their ability to generate shareholder returns [1]
Altimmune: Upcoming MASH Data Could Be High Impact For Business Development Activity
Seeking Alpha· 2025-05-29 14:25
Altimmune Inc. ( ALT ) has an upcoming readout from the IMPACT phase 2b study of pemvidutide in metabolic dysfunction-associated steatohepatitis [MASH]. I rated ALT a buy in December 2024, based on the idea that pemvidutide's profile and ALT's valuationScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analys ...
ALT5 Sigma Integrates Lightning Network with Voltage to Enable Instant Bitcoin Payments
Prnewswire· 2025-05-27 13:00
LAS VEGAS, May 27, 2025 /PRNewswire/ -- ALT5 Sigma Corporation (the "Company" or "ALT5") (NASDAQ: ALTS) (FRA: 5AR1), a fintech company providing blockchain-powered payment and trading infrastructure for global merchants and financial institutions, today announced it has enabled Lightning Network payment capabilities through a partnership with Voltage, a leading provider of enterprise-grade Lightning infrastructure. ALT5 Sigma Integrates Lightning Network with Voltage to Enable Instant Bitcoin Payments ...
Altimmune(ALT) - 2025 FY - Earnings Call Transcript
2025-05-20 15:00
Altimmune (ALT) FY 2025 Conference May 20, 2025 10:00 AM ET Speaker0 Come to the third annual HC Wainwright BioConnect Conference. I'm Patrick Trucchio, senior health care analyst at HC Wainwright. It's my pleasure to have the management of Altimmune with us, president CEO, Vipin Gard, and CMO, Scott Harris. Welcome to Bioconut, once again, and it's a pleasure to have you with us. And it's always great to catch up on the pipeline. I think, maybe first, we'll start with MVDU, Ty, just some background on MVDU ...
Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD)
Globenewswire· 2025-05-19 11:30
Core Insights - Altimmune, Inc. has initiated the RECLAIM Phase 2 trial for pemvidutide, targeting Alcohol Use Disorder (AUD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD, and alcohol liver disease (ALD) [1][4] - The trial will enroll approximately 100 subjects and assess changes in alcohol consumption and related biomarkers [2][3] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on peptide-based therapeutics for liver and cardiometabolic diseases [4] - The lead program, pemvidutide, is designed to address multiple conditions including MASH, obesity, AUD, and ALD [4] Industry Context - Over 28 million individuals in the U.S. are affected by AUD, with less than 10% currently receiving treatment [3] - Existing medications for AUD have limited effects and compliance rates, highlighting the need for new therapies [3] - Pemvidutide has shown promising preclinical results, significantly reducing alcohol preference in animal models [3]
Altimmune(ALT) - 2025 Q1 - Quarterly Report
2025-05-13 20:55
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-32587 ALTIMMUNE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-2726770 (State or Oth ...
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]