Altimmune, Inc. develops pemvidutide, a late clinical-stage dual-action therapy targeting glucagon and GLP-1 receptors for serious liver diseases. Company news centers on pemvidutide development in metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD), including clinical trial updates and FDA designations such as Fast Track and Breakthrough Therapy Designation where granted.
Altimmune updates also cover financial results, business updates, investor conference participation and capital actions used to fund development activity. Recurring financing news includes public offerings, registered direct offerings, common stock, pre-funded warrants and common stock warrants.
Altimmune announced the commencement of enrollment in its Phase 1 clinical trial for AdCOVID, a novel intranasal COVID-19 vaccine. The company reported a significant increase in cash reserves to $216 million, up from $37 million year-over-year. Revenue rose to $8.2 million, driven by U.S. government contracts. However, net loss attributed to common stockholders increased to $49 million, reflecting higher R&D and administrative expenses. The company is advancing multiple clinical trials, including ALT-801 and T-COVID, with data readouts expected in 2021.
Altimmune plans to report its full year 2020 financial results on February 25, 2021. The company will hold a conference call at 8:30 AM ET to discuss these results and provide a business update. Altimmune focuses on developing intranasal vaccines and immune modulating therapies, with a diverse pipeline including products for COVID-19, anthrax, influenza, and liver disease. The company's offerings include AdCOVID™, NasoShield™, NasoVAX™, T-COVID™, ALT-801, and HepTcell™.
Altimmune, Inc. (Nasdaq: ALT) has received FDA clearance for its Phase 1 clinical trial of AdCOVID, a single-dose, intranasal COVID-19 vaccine, with patient enrollment set to begin next week. The trial aims to evaluate the safety and immunogenicity of AdCOVID in 180 healthy adults aged 18 to 55. Preclinical studies have shown promising immune responses, and AdCOVID is designed to stimulate both systemic and mucosal immunity. The company anticipates that this vaccine could be stored at room temperature, potentially facilitating broader distribution.
Altimmune has initiated a Phase 2 clinical trial for HepTcell, an innovative immunotherapeutic designed to treat chronic hepatitis B (CHB). Conducted across the U.S., Canada, and Europe, this double-blind study includes 80 adults and will assess safety and efficacy over 24 weeks, with a focus on virological response. CHB affects 292 million globally, with no current cure, leading to significant health risks. HepTcell aims to restore T cell function, addressing a critical unmet need in CHB therapy.
Altimmune, Inc. (Nasdaq: ALT) announced a clinical hold by the FDA on its IND application for AdCOVID, an intranasal COVID-19 vaccine. The FDA has requested protocol modifications and additional CMC data. Altimmune has addressed these requests and does not foresee a significant delay in its clinical development timeline. The company is preparing to initiate a Phase 1 clinical trial for AdCOVID, which has demonstrated promising preclinical results showing robust immune responses against COVID-19.
Altimmune, Inc. (Nasdaq: ALT) announced that Dr. Scott Harris, their Chief Medical Officer, will present on ALT-801, a promising GLP-1/glucagon dual receptor agonist aimed at treating non-alcoholic steatohepatitis (NASH). This presentation is part of the 4th Annual NASH Summit 2020 Digital Conference, taking place from December 15-18, 2020. Dr. Harris will also join a panel discussion on NASH treatments on December 16. ALT-801 shows potential in addressing obesity linked to NASH, with Phase 1 data expected in Q2 2021.
Altimmune, Inc. has initiated dosing in a Phase 1 clinical trial for ALT-801, a dual GLP-1/glucagon receptor agonist targeting non-alcoholic steatohepatitis (NASH), affecting over 13 million adults in the U.S. The trial in Australia will evaluate safety, pharmacokinetics, and activity in 50-60 volunteers. Initial results, including weight loss and liver fat reduction, are expected in Q2 2021, with a follow-up Phase 1b study planned for Q3 2021. The drug aims to improve tolerability and efficacy in treating NASH compared to existing therapies.
Altimmune has submitted an Investigational New Drug (IND) application for its single-dose intranasal COVID-19 vaccine, AdCOVID, to the FDA. AdCOVID aims to stimulate comprehensive immunity, including local nasal mucosal immunity, crucial for preventing virus transmission. The Phase 1 trial is expected to begin in Q4 2020, with data readout anticipated in Q1 2021. The vaccine's advantages include easy administration, room-temperature transport, and potential pediatric use. The FDA has approved the study design and patient population, deeming no additional toxicology studies necessary.
Altimmune, Inc. (Nasdaq: ALT) announced its participation in upcoming virtual investor conferences. These events include the Jefferies London Virtual Healthcare Conference on November 17, 2020, the Piper Sandler 32nd Annual Virtual Healthcare Conference from November 23 to December 3, 2020, and the 3rd Annual Evercore ISI Virtual HealthCONx Conference on December 2, 2020. All sessions will be accessible through the investor relations section of Altimmune's website. The company focuses on developing intranasal vaccines and therapies for diseases, including COVID-19 and liver disease.
Altimmune has announced an agreement with Lonza to manufacture its AdCOVID intranasal vaccine for COVID-19. This partnership aims to enhance Altimmune's commercial readiness for potential vaccine distribution in 2021. The AdCOVID vaccine is designed for easy administration and aims to provide broad immune responses, including mucosal immunity. Preclinical studies indicate a significant increase in mucosal IgA. The company plans to initiate a Phase 1 clinical trial in Q4 2020, with results expected in Q1 2021.