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Altimmune (NasdaqGM:ALT) Earnings Call Presentation
2025-11-06 21:00
Altimmune Corporate Overview November 2025 Our Mission: To Revolutionize the Standard of Care for Serious Liver Diseases Forward Looking Statements Safe-Harbor Statement This presentation has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, pla ...
Altimmune(ALT) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:30
Financial Data and Key Metrics Changes - Total cash as of September 30 was $211 million, representing a 60% increase from the beginning of the year [11] - R&D expenses for Q3 2025 were $15 million, down from $19.8 million in Q3 2024, primarily due to the timing of CRO development costs [12] - Net loss for Q3 2025 was $19 million or $0.21 per share, compared to a net loss of $22.8 million or $0.32 per share in Q3 2024 [13] Business Line Data and Key Metrics Changes - Direct costs related to Pemvidutide development in Q3 2025 included $9.2 million, with $3.7 million for the IMPACT phase 2b trial, $3.4 million for AUD and ALD startup costs, and $1.3 million for CMC [12] Market Data and Key Metrics Changes - Market research indicated that 70%-80% of surveyed physicians expressed a high likelihood to prescribe Pemvidutide based on its product profile [7] - Positive feedback from payers suggested broad coverage expectations across the EU for Pemvidutide [8] Company Strategy and Development Direction - The company is preparing for a scheduled end-of-phase two meeting with the FDA to review the proposed phase three MASH program [2][15] - Pemvidutide is positioned as a promising therapeutic candidate for MASH, AUD, and ALD, leveraging its dual mechanism of action [3][5] - The company aims to design a flexible phase three trial to adapt to potential regulatory changes regarding endpoints [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the 24-week data supporting the upcoming discussions with the FDA [18][19] - The company anticipates continued weight loss and improvements in NITs at the 48-week mark, reinforcing the efficacy of Pemvidutide [20][35] Other Important Information - The company has raised $127 million through various capital sourcing options to support key development milestones [11] - A $400 million shelf registration and a new $200 million ATM facility were filed to enhance financial flexibility [12] Q&A Session Summary Question: Upcoming 48-week data from the phase two IMPACT trial - Management indicated that the end-of-phase two meeting with the FDA was based on the 24-week data, and the 48-week data would be submitted later [18][19] Question: Probability of using NITs or AI-based histological reading - Management noted ongoing discussions and increasing interest in NITs, with flexibility built into the phase three design to adapt to regulatory changes [25] Question: Advantages of AI-based biopsy reading - AI provides a more comprehensive evaluation of fibrosis with less variability compared to traditional histology, which is subject to human error [25][26] Question: Clinically meaningful endpoint for the RECLAIM trial - The primary endpoint for the RECLAIM trial is the number of heavy drinking days per week, with a focus on assessing changes from baseline [28][31] Question: Competitive positioning against Retatrutide - Management believes Pemvidutide's dual mechanism of action provides a competitive advantage in the MASH space compared to Retatrutide [64][65] Question: Progress on the oral formulation of Pemvidutide - The company is advancing its oral formulation program and plans to share more data as it progresses [70]
FINAL DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Altimmune
Businesswire· 2025-10-06 17:58
Core Points - Faruqi & Faruqi, LLP is investigating potential claims against Altimmune, Inc. and reminds investors of the October 6, 2025 deadline to seek the role of lead plaintiff in a federal securities class action against the company [2][3] Company Performance - On June 26, 2025, Altimmune announced topline results from the IMPACT Phase 2b MASH trial of Pemvidutide, which failed to achieve statistical significance in its primary endpoint of fibrosis reduction, despite prior inflated expectations [4] - Following the announcement, Altimmune's stock price plummeted from $7.71 per share on June 25, 2025, to $3.61 per share on June 26, 2025, marking a decline of 53.2% in just one day [5]
ALTIMMUNE FINAL DEADLINE REMINDER: Bragar Eagel & Squire, P.C. Urges Investors to Contact the Firm Regarding the October 6th Deadline
Globenewswire· 2025-10-06 14:09
Core Viewpoint - A class action lawsuit has been filed against Altimmune, Inc. for alleged inflated expectations regarding the results of its IMPACT Phase 2b MASH trial, leading to significant stock price decline [8]. Allegation Details - The lawsuit claims that Altimmune failed to achieve statistical significance in the primary endpoint of fibrosis reduction in the trial, despite previously optimistic projections [8]. - Following the announcement of the trial results on June 26, 2025, Altimmune's stock price plummeted from $7.71 to $3.61, a decrease of 53.2% in one day [8]. Next Steps - Investors who purchased Altimmune securities between August 10, 2023, and June 25, 2025, are encouraged to contact the law firm for more information and to discuss their legal rights [4][8].
The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Altimmune, Inc.(ALT) Shareholders
Prnewswire· 2025-10-06 12:45
Core Viewpoint - Altimmune, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the results of its IMPACT Phase 2b MASH trial for Pemvidutide, which led to a significant drop in its stock price following the announcement of trial results that did not meet statistical significance [1][2]. Group 1: Allegations and Impact - The class action is based on a complaint that claims Altimmune provided inflated expectations prior to the announcement of the trial results on June 26, 2025 [1]. - The trial results showed a failure to achieve statistical significance in the primary endpoint of fibrosis reduction, attributed to a higher-than-expected placebo response [1]. - Following the announcement, Altimmune's stock price plummeted from $7.71 per share on June 25, 2025, to $3.61 per share on June 26, 2025, marking a decline of 53.2% in one day [1]. Group 2: Next Steps for Shareholders - Shareholders who purchased shares of ALT during the specified class period are encouraged to register for the class action by October 6, 2025, to potentially become lead plaintiffs [2]. - Registered shareholders will be enrolled in a portfolio monitoring software to receive updates on the case [2]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].
ALT INVESTOR NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Altimmune
Globenewswire· 2025-10-06 03:40
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Altimmune, Inc. following a significant decline in its stock price after the announcement of disappointing trial results for Pemvidutide [4][6][7] Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Altimmune to contact them to discuss their legal options [1][9] - There is a deadline of October 6, 2025, for investors to seek the role of lead plaintiff in a federal securities class action against Altimmune [4][8] Group 2: Company Performance - On June 26, 2025, Altimmune announced topline results from the IMPACT Phase 2b MASH trial, which failed to achieve statistical significance in its primary endpoint of fibrosis reduction [6] - The stock price of Altimmune fell from $7.71 per share on June 25, 2025, to $3.61 per share on June 26, 2025, marking a decline of 53.2% in one day [7]
ALTIMMUNE CLASS ACTION REMINDER: Bragar Eagel & Squire, P.C. Reminds Investors of October 6th Deadline and Urges Investors to Contact the Firm
Globenewswire· 2025-10-03 15:06
Core Viewpoint - A class action lawsuit has been filed against Altimmune, Inc. for allegedly misleading investors regarding the results of its IMPACT Phase 2b MASH trial, leading to significant stock price decline [8]. Allegation Details - The lawsuit claims that Altimmune provided inflated expectations prior to the announcement of the trial results, which revealed a failure to achieve statistical significance in the primary endpoint of fibrosis reduction [8]. - Following the announcement on June 26, 2025, Altimmune's stock price plummeted from $7.71 to $3.61, marking a 53.2% decline in one day [8]. Next Steps - Investors who purchased Altimmune securities between August 10, 2023, and June 25, 2025, are encouraged to contact the law firm for more information and to discuss their legal rights [4][8].
SHAREHOLDER REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Altimmune
Prnewswire· 2025-10-03 13:50
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Altimmune, Inc. following a significant decline in its stock price after disappointing trial results for Pemvidutide, urging affected investors to discuss their legal options [1][3][4]. Group 1: Company Overview - Altimmune, Inc. is a biopharmaceutical company involved in developing treatments, including Pemvidutide for MASH [3]. - The company faced a setback when it failed to achieve statistical significance in its Phase 2b MASH trial, leading to inflated expectations prior to the announcement [3]. Group 2: Stock Performance - Following the announcement of the trial results on June 26, 2025, Altimmune's stock price plummeted from $7.71 to $3.61 per share, marking a decline of 53.2% in one day [4]. Group 3: Legal Actions - A federal securities class action has been filed against Altimmune, with a deadline of October 6, 2025, for investors to seek the role of lead plaintiff [1][5]. - The lead plaintiff is defined as the investor with the largest financial interest who can adequately represent the class [5].
Investors in Altimmune, Inc. Should Contact Levi & Korsinsky Before October 6, 2025 to Discuss Your Rights - ALT
Prnewswire· 2025-10-01 12:45
Core Points - A class action securities lawsuit has been filed against Altimmune, Inc. for alleged securities fraud affecting investors between August 10, 2023, and June 25, 2025 [1] - The lawsuit follows a significant decline in Altimmune's stock price after the announcement of disappointing results from the IMPACT Phase 2b MASH trial of Pemvidutide, where the primary endpoint of fibrosis reduction did not achieve statistical significance [2] - Investors who suffered losses during the relevant time frame have until October 6, 2025, to request to be appointed as lead plaintiff, with no out-of-pocket costs to participate in the class action [3] Company Details - On June 26, 2025, Altimmune reported that the IMPACT Phase 2b MASH trial did not meet the expected statistical significance for fibrosis reduction, leading to a 53.2% drop in stock price from $7.71 to $3.61 per share in one day [2] - The company attributed the disappointing results to the Phase 2 nature of the trial and expressed hope for better outcomes in the upcoming Phase 3 trial [2] Legal Representation - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years and consistently ranking among the top securities litigation firms in the U.S. [4]
Altimmune, Inc. (NASDAQ: ALT) Deadline Approaching: Berger Montague Advises Investors of Deadline in Securities Fraud Lawsuit
Prnewswire· 2025-10-01 12:13
Core Viewpoint - A class action lawsuit has been filed against Altimmune Inc. by Berger Montague PC on behalf of investors who acquired Altimmune securities between August 10, 2023, and June 25, 2025, following disappointing trial results for its drug Pemvidutide [1][2][3]. Company Overview - Altimmune Inc. is a clinical-stage biopharmaceutical company based in Gaithersburg, Maryland, focusing on therapeutics for obesity and liver disease, including MASH (metabolic dysfunction-associated steatohepatitis) [2]. Legal Action Details - The lawsuit is based on a press release issued by Altimmune on June 26, 2025, which announced that the IMPACT Phase 2b trial of Pemvidutide failed to achieve statistical significance in its primary endpoint related to fibrosis reduction, attributed to a higher-than-expected placebo response [3]. - Following the announcement, Altimmune's stock price plummeted by 53.2%, dropping from a close of $7.71 on June 25, 2025, to $3.61 on June 26, 2025 [4]. Investor Information - Investors who purchased Altimmune securities during the class period have until October 6, 2025, to seek appointment as lead plaintiff representatives [2].