Welcome to our dedicated page for Appili Ther news (Ticker: APLIF), a resource for investors and traders seeking the latest updates and insights on Appili Ther stock.
News about Appili Therapeutics Inc. (APLIF) focuses on its progress as an infectious disease biopharmaceutical company developing anti-infective therapies and medical countermeasures. Company updates highlight commercial performance of its FDA-approved metronidazole oral suspension LIKMEZ, advancement of its tularemia vaccine candidate ATI-1701, development of the topical antiparasitic ATI-1801 for cutaneous leishmaniasis, and its collaboration with Vitalex Biosciences on the fungal vaccine program VXV-01.
Investors and observers following Appili’s news can track announcements on government contracts and grants, including cooperative agreements with the U.S. Air Force Academy and a NIAID contract valued at up to US$40 million for VXV-01. Releases also describe multiple additional U.S. federal funding proposals that could support manufacturing, nonclinical and preclinical studies, regulatory work, IND submissions, and Phase 1 clinical trials across the company’s pipeline.
Regular news items include financial and operational results, scientific publications in peer-reviewed journals, and presentations at sector events such as the NATO Chemical, Biological, Radiological and Nuclear Conference, the BARDA Innovation Symposium, and biodefense consortium meetings. These updates provide context on ATI-1701’s preclinical data, ATI-1801’s regulatory interactions with the FDA, and LIKMEZ patent developments and commercialization activities.
By reviewing Appili Therapeutics news on this page, readers can follow how the company’s infectious disease and biodefense programs evolve over time, how non-dilutive government funding contributes to its development plans, and how its commercial and pipeline assets may influence the outlook for APLIF stock.
Appili Therapeutics announced that its Phase 3 PRESECO clinical trial of Avigan®/Reeqonus™ (favipiravir) for mild-to-moderate COVID-19 patients failed to meet the primary endpoint of sustained clinical recovery. The trial enrolled 1,231 patients across 38 sites in the United States, Mexico, and Brazil. Despite this disappointment, Appili remains committed to developing effective treatments for COVID-19 and other infectious diseases. Ongoing analyses of trial data may enhance future research efforts.
AiPharma Global Holdings and Appili Therapeutics have announced a strategic alliance to advance the global development of Avigan®/Reeqonus™ (favipiravir), an oral antiviral under evaluation for COVID-19. Under this agreement, AiPharma will acquire approximately 19.4% of Appili's shares, while Appili will receive around 6% of AiPharma. With Avigan® authorized in nine countries and over 1.5 million patients treated in 2021, the partnership aims to enhance pandemic preparedness and expedite clinical advancements. Both companies will form a joint steering committee to oversee development and regulatory activities.
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) enters a strategic alliance with AiPharma to advance the global development of Avigan®/Reeqonus™ (favipiravir) for COVID-19 treatment. The agreement enhances resource capabilities and establishes a joint scientific steering committee to streamline development. AiPharma gains a 50% equity stake in Global Response Aid, boosting cash flow prospects from Avigan sales. The equity transaction allows for mutual investment interests, with closing expected in Q4 2021, pending TSX approval.
Appili Therapeutics (TSX: APLI; OTCQX: APLIF) announced the completion of patient enrollment in its Phase 3 PRESECO trial, evaluating Avigan®/Reeqonus™ (favipiravir) for COVID-19 treatment. The trial has enrolled 1,231 patients across 38 sites in the US, Mexico, and Brazil, targeting the Delta variant. The primary goal is to assess the treatment's impact on symptom resolution and progression to severe disease. Results are expected in approximately 60 days, marking a significant milestone for Appili in the fight against COVID-19.
Appili Therapeutics (APLIF) has secured $1 million in funding from FUJIFILM Toyama Chemical Co., Ltd. to expedite its Phase 3 PRESECO clinical trial for the antiviral drug Avigan/Reeqonus in treating COVID-19. This funding supports key activities as Appili prepares for database lock and top-line results. The PRESECO trial aims to evaluate the safety and efficacy of Avigan/Reeqonus for mild-to-moderate COVID-19 patients, with expanded enrollment to include cases of COVID-19 variants. FFTC will gain access to PRESECO data for regulatory submissions in Japan.
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) has completed patient enrollment in the viral shedding sub-study of its Phase 3 PRESECO trial for the antiviral drug Avigan®/Reeqonus™ (favipiravir) aimed at treating COVID-19. Over 550 patients are enrolled to assess the drug's efficacy against emerging variants, including Delta. The sub-study's results will be released alongside PRESECO's top-line results. The study, conducted in the U.S., Brazil, and Mexico, targets adults with mild-to-moderate COVID-19 symptoms.
Appili Therapeutics announced the results of its annual general meeting held on September 7, 2021, highlighting shareholder approval of all resolutions. Josef Vejvoda has been elected to the Board of Directors, bringing over 25 years of capital markets experience. Voting results indicate strong support for board members, including Ian Mortimer and Brian Bloom, with percentages of votes for exceeding 99%. Additionally, PricewaterhouseCoopers was reappointed as the independent auditor. Appili focuses on developing novel therapies for infectious diseases, including ongoing trials for the antiviral Avigan/Reeqonus.
Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) reported its financial results for Q1 2022, ending June 30, 2021. The company incurred a net loss of $7.4 million ($0.12 per share), up from $2.6 million ($0.05 per share) in Q1 2021, largely due to increased R&D expenses. Operationally, it completed an interim analysis for the Phase 3 PRESECO trial of Avigan®/Reeqonus™ for COVID-19, receiving a recommendation to continue. The trial has expanded into Latin America, and the company secured $3.5 million in funding for its pipeline.
Appili Therapeutics (TSX: APLI; OTCQX: APLIF) reported its fiscal year results for 2021, showing a net loss of $14.3 million, up from $5.4 million in 2020. Research and development expenses rose by $8.1 million. The company has $16.1 million in cash and working capital of $13.6 million. Appili is encouraged by the independent monitoring board's recommendation to continue its Phase 3 PRESECO trial for Avigan/Reeqonus, targeting COVID-19. The company aims to advance its pipeline, including a $6.3 million grant for its ATI-1701 vaccine program.
Appili Therapeutics (OTCQX: APLIF) expands its Phase 3 PRESECO clinical trial of Avigan®/Reeqonus™ (favipiravir) for COVID-19 by adding clinical research sites in Mexico and Brazil. This move aims to expedite enrollment and trials completion, with top-line data expected by Q3 2021. The study focuses on a potential home treatment for mild-to-moderate COVID-19 patients. An independent Data and Safety Monitoring Board has recommended proceeding without modifications. The CONTROL trial is ended to prioritize PRESECO, and a future Phase 3 PEPCO study is planned for post-exposure prophylaxis.