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Altimmune, Inc. (ALT) Discusses Topline 48-Week Results From IMPACT Phase IIb Trial of Pemvidutide in MASH Transcript
Seeking Alpha· 2025-12-19 16:37
Core Viewpoint - The company is preparing to discuss the results of a trial, emphasizing the importance of the press release available on their Investor Relations website [2] Group 1 - The call will include prepared remarks from management followed by a Q&A session [2] - The company highlights that remarks regarding future expectations are forward-looking statements protected under the Private Securities Litigation Reform Act of 1995 [2] - The company cautions that these forward-looking statements are subject to risks and uncertainties that could lead to actual results differing materially from expectations [2]
Altimmune (NasdaqGM:ALT) Update / Briefing Transcript
2025-12-19 14:02
Summary of Altimmune Conference Call Company and Industry - **Company**: Altimmune - **Industry**: Pharmaceutical/Biotechnology, specifically focusing on liver diseases such as MASH (Metabolic Associated Steatotic Liver Disease) Key Points and Arguments 1. **IMPACT Phase 2b Trial Results**: The 48-week data from the IMPACT trial of Pembidutide in MASH showed significant improvements in non-invasive markers of fibrosis, with continued reductions from the 24-week time point [4][21] 2. **Weight Loss**: The 1.8-milligram dose of Pembidutide resulted in additional weight loss from 24 to 48 weeks, with no evidence of plateauing [4][21] 3. **FDA Engagement**: Altimmune had a productive end-of-phase 2 meeting with the FDA, aligning on the registration of the phase 3 program for MASH patients with moderate to advanced fibrosis [17][18] 4. **Tolerability Profile**: Pembidutide demonstrated a favorable tolerability profile, critical for maintaining patients on therapy, especially in a chronic disease setting like MASH [15][16] 5. **Dose Response**: The data indicated a clear dose response, supporting the focus on the 1.8-milligram dose for phase 3 trials, with potential for a 2.4-milligram maintenance dose [8][15] 6. **Comparison with Other Therapies**: Pembidutide's improvements in ELF and liver stiffness measurements were favorable compared to currently approved therapies like Resmetirom and Semaglutide [12][13] 7. **Safety Profile**: No serious adverse events were reported, and the majority of adverse events were mild to moderate, with good glycemic control maintained in diabetic patients [15][16] 8. **Regulatory Strategy**: The primary endpoint for the phase 3 trial will be biopsy-driven, but there is potential for incorporating non-invasive tests (NITs) as the FDA's stance evolves [42][43] 9. **Sample Size for Phase 3**: The expected sample size for the phase 3 trial is between 1,000 to 1,500 patients, with discussions ongoing with the FDA [40][41] 10. **Future Plans**: Altimmune plans to initiate the phase 3 MASH trial in 2026, with additional trials for other indications like AUD (Alcohol Use Disorder) and ALD (Alcoholic Liver Disease) [20][21] Other Important but Overlooked Content 1. **AI Tool Utilization**: The FDA is open to incorporating the AIM-MASH AI pathology tool to improve standardization in biopsy readings, which could reduce variability in the consensus read process [18][43] 2. **Long-term Outcomes**: The phase 3 study will follow patients for up to 60 months to assess liver-related events, with potential for future studies in F4 populations [41] 3. **Market Research Insights**: Payers are increasingly focused on early response indicators and adherence to chronic therapies, which could influence reimbursement decisions [38][39] 4. **Differentiation from Competitors**: Pembidutide's unique mechanism and tolerability profile may provide a competitive edge over existing therapies in the market [28][29] This summary encapsulates the critical insights from the Altimmune conference call, highlighting the company's advancements in the treatment of MASH and its strategic direction moving forward.
Altimmune's drug for a type of liver disease shows benefits in mid-stage study
Reuters· 2025-12-19 11:42
Core Viewpoint - Altimmune's experimental drug has shown positive results in improving liver scarring and overall liver health after 48 weeks of treatment in a mid-stage study focused on patients with serious fatty liver disease [1] Group 1 - The drug demonstrated significant improvement in liver health indicators after a 48-week treatment period [1] - The study involved patients suffering from a serious condition known as fatty liver disease [1]
Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial
Globenewswire· 2025-12-19 11:30
Core Insights - Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks [2][3] Group 1: Trial Results - Statistically significant improvements in key non-invasive markers of fibrosis, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), were observed across treatment arms compared to placebo [3][5] - The 1.2 mg and 1.8 mg doses of pemvidutide achieved mean reductions in ELF of -0.49 and -0.58 respectively, versus +0.16 in placebo (p<0.0001) [5] - The 1.2 mg and 1.8 mg doses achieved mean reductions in LSM of -3.04 (p<0.05) and -3.97 (p<0.001) respectively, compared to -0.03 in placebo [5] - Participants receiving pemvidutide also showed significant reductions in liver fat content, alanine aminotransferase (ALT), and corrected T1 (cT1) [5] - Weight loss was observed with the 1.2 mg and 1.8 mg doses at 4.5% and 7.5% respectively, compared to 0.2% in placebo (p<0.0001) [13] Group 2: Tolerability and Safety - The tolerability profile of pemvidutide was favorable at 48 weeks, with low treatment-related discontinuation rates of 0% and 1.2% for the 1.2 mg and 1.8 mg doses respectively, compared to 3.5% for placebo [13] - No serious or severe adverse events related to treatment were reported [13] Group 3: Regulatory Progress - The company held a productive End-of-Phase 2 meeting with the FDA, aligning on parameters for a registrational Phase 3 trial for pemvidutide in MASH patients with moderate to advanced liver fibrosis [6][7] - The FDA's qualification of AIM-MASH AI Assist was noted, which aims to standardize histologic assessment in the Phase 3 trial [6] Group 4: Future Plans - The company plans to initiate the Phase 3 program for pemvidutide in 2026, leveraging the strong evidence of antifibrotic improvements and favorable tolerability [7]
ALT5 INVESTIGATION ALERT: Investigation Launched into ALT5 Sigma Corporation, Attorneys Encourage Investors and Potential Witnesses to Contact Law Firm - ALTS
Prnewswire· 2025-12-12 04:15
Core Insights - Robbins Geller Rudman & Dowd LLP is investigating potential violations of U.S. federal securities laws involving ALT5 Sigma Corporation, focusing on whether the company and its executives made false or misleading statements or failed to disclose material information to investors [1][2] Company Overview - ALT5 Sigma provides blockchain-powered technologies through its Fintech and Biotechnology segments [2] - On August 11, 2025, ALT5 Sigma announced plans to raise approximately $1.5 billion before fees through a registered direct offering and a private placement offering [2] Recent Developments - On August 29, 2025, ALT5 Sigma disclosed a judgment from the Intermediate Court of Nyarugenge, Rwanda, finding its subsidiary criminally liable for offenses including illicit enrichment and money laundering [3] - An independent committee was appointed by the Board to investigate potential misstatements or omissions in the financial statements [3] - On October 22, 2025, Peter Tassiopoulos was suspended as CEO, effective immediately, with pay [3] - ALT5 Sigma announced on November 18, 2025, that it would not file its Quarterly Report on Form 10-Q for that quarter in a timely manner [3] - A leadership overhaul occurred on November 27, 2025, with the rapid departures of the CFO, Acting CEO, and COO, alongside the appointment of a new Acting CEO and an experienced CFO [3] - On November 28, 2025, ALT5 Sigma's independent registered public accounting firm resigned due to the retirement of its sole partner [3] - On December 3, 2025, ALT5 Sigma received a notice from Nasdaq regarding non-compliance with listing requirements due to the resignation of a Board member [3]
Does Altimmune (ALT) Have the Potential to Rally 229.28% as Wall Street Analysts Expect?
ZACKS· 2025-12-11 15:56
Core Viewpoint - Altimmune, Inc. (ALT) has shown a significant price increase of 28.4% over the past four weeks, with a mean price target of $17.88 indicating a potential upside of 229.3% from the current price of $5.43 [1] Price Targets and Analyst Consensus - The average price target for ALT includes eight short-term estimates ranging from a low of $1.00 to a high of $28.00, with a standard deviation of $8.81, indicating variability in analyst predictions [2] - The lowest estimate suggests a decline of 81.6%, while the highest points to an upside of 415.7% [2] - A low standard deviation among price targets suggests a strong agreement among analysts regarding the stock's price direction, which can be a useful starting point for further research [9] Earnings Estimates and Analyst Optimism - Analysts have shown increasing optimism about ALT's earnings prospects, as indicated by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 1.8%, with one estimate moving higher and no negative revisions [12] - ALT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] Caution on Price Targets - While the consensus price target is a commonly referenced metric, relying solely on it for investment decisions may not be prudent due to historical inaccuracies in predicting actual stock price movements [3][7] - Analysts often set optimistic price targets influenced by business relationships, which can lead to inflated estimates [8] - Investors should approach price targets with skepticism and consider them as one of many factors in their decision-making process [10]
ALT5 Sigma Corporation Provides Strategic Overview of $WLFI Treasury Strategy, USD1 Stablecoin Utility and Its Relevance to the Company's Future Payment Infrastructure
Businesswire· 2025-12-11 13:08
Core Insights - ALT5 Sigma Corporation has released a strategic overview regarding the USD1 stablecoin and its significance to the company's long-term payments technology product [1] - The company is a prominent holder of $WLFI, which is the governance token of the World Lib [1] Company Overview - ALT5 Sigma Corporation operates in the fintech sector, focusing on global payments, trading, and settlement infrastructure [1] - The anticipated benefits of the USD1 stablecoin are expected to enhance the company's $WLFI Treasury Strategy [1]
ALT5 ALERT: Bragar Eagel & Squire, P.C. is Investigating ALT5 Sigma Corp on Behalf of ALT5 Stockholders and Encourages Investors to Contact the Firm
Globenewswire· 2025-12-09 23:13
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against ALT5 Sigma Corp for possible violations of federal securities laws and unlawful business practices affecting stockholders [1][2]. Investigation Details - The investigation is focused on whether ALT5 has engaged in unlawful activities that may have led to financial losses for investors [1][2]. - Investors who have suffered losses and wish to discuss their legal rights are encouraged to contact the law firm [3]. Company Developments - On August 29, 2025, ALT5 disclosed that its subsidiary was found criminally liable for illicit enrichment and money laundering, leading to a significant drop in share price by approximately 29.2% [6]. - Following the suspension of CEO Peter Tassiopoulos on October 22, 2025, the share price fell by about 8.8% [6]. - ALT5 announced delays in filing its quarterly report due to ongoing reviews and issues with its outside auditor [6]. - The company terminated CFO and acting CEO Jonathan Hugh on November 26, 2025, and the Audit Committee Chair resigned from the board [6]. - On November 28, 2025, ALT5's outside auditor resigned on the same day as the CFO's termination [6].
ALT5 Sigma Corporation Provides Corporate Update
Businesswire· 2025-12-09 12:30
Core Viewpoint - ALT5 Sigma Corporation is advancing its strategic $WLFI digital asset treasury initiative, focusing on innovation and agility to drive growth across its business segments [2][3]. Group 1: $WLFI Treasury Strategy - ALT5 launched the $WLFI Treasury strategy to gain structured exposure to the $WLFI ecosystem and optimize the number of $WLFI tokens held per share through strategic capital deployment [3]. - The treasury strategy aims to strengthen ALT5's balance sheet and enhance long-term capital flexibility, creating synergies across payments, trading, settlement, and digital asset treasury operations [3]. - As of December 8, 2025, ALT5 holds approximately 7.28 billion $WLFI tokens, valued at around $1.1 billion, with a market price of $0.15 per token [6]. Group 2: Fintech & Payments Business - ALT5's Fintech & Payments business includes ALT5 Pay and ALT5 Prime, which have processed over $5 billion in cryptocurrency transactions, highlighting their scale and reliability [7]. - ALT5 Pay facilitates secure digital asset transactions and supports crypto-to-fiat and fiat-to-crypto conversions, enabling real-time global payment flows [8]. - ALT5 Prime provides traditional financial institutions with access to digital asset trading and real-time settlement, generating revenue from spread capture and transaction fees [9][10]. Group 3: Biotech Business - ALT5's legacy biotech business, Alyea Therapeutics Corporation, is focused on advancing clinical trials for non-addictive pain treatment patents, aiming to increase the business's realizable value [12]. Group 4: Future Outlook - ALT5 believes that the advancements in its $WLFI Treasury strategy and the integration of $USD1 across its platforms position the company for sustained innovation and growth in digital finance solutions [13].
Altimmune: 48-Week MASH Data Due This Month Is Make Or Break For The Company (NASDAQ:ALT)
Seeking Alpha· 2025-12-04 16:35
Group 1 - The article discusses the investment potential of Altimmune, Inc. (ALT), focusing on its lead drug candidate, pemvidutide, which is the only drug in its pipeline [1] - The author emphasizes the importance of staying updated on stocks in the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1] - The investing group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including product sales forecasts and financial analyses for major pharmaceutical companies [1] Group 2 - The article is authored by a biotech consultant with over five years of experience in the industry, who has prepared detailed reports on more than 1,000 companies [1] - The newsletter aims to offer buy and sell ratings, as well as catalysts to monitor for investment opportunities in the biotech sector [1]