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Appili Therapeutics Inc. develops anti-infective products for infectious diseases and biodefense. Company updates cover its portfolio of LIKMEZ (ATI-1501), an FDA-approved ready-made metronidazole suspension; ATI-1701, a live-attenuated tularemia vaccine candidate; ATI-1801, a topical antiparasitic program for cutaneous leishmaniasis; and collaborations involving VXV-01, a fungal vaccine program.
Recurring news also addresses non-dilutive government funding, NIAID and U.S. Air Force Academy-supported development work, manufacturing and regulatory activities, financial and operational results, scientific and biodefense conference participation, and shareholder meeting outcomes.
Appili Therapeutics (TSX: APLI; OTCQX: APLIF) has announced an expansion of its agreement with Saptalis Pharmaceuticals to commercialize ATI-1501 in Europe and Latin America. This liquid oral formulation of metronidazole aims to enhance accessibility for patients who struggle with solid doses. An NDA filing with the US FDA is anticipated later this year, with Appili supporting clinical development. Recent milestones include a payment for successful ATI-1501 batch production, positioning the company for potential royalty income from expanded sales channels.
Appili Therapeutics (TSX:APLI; OTCQX:APLIF) announced positive results from a preclinical study of its biodefense vaccine candidate ATI-1701. The study showed a survival rate of 29% in vaccinated animals against Francisella tularensis, compared to 0% in controls, at one year post-vaccination. Previous results indicated 100% survival at 90 days. Dr. Armand Balboni expressed optimism about the vaccine's potential as a leading candidate against tularemia, while noting ongoing development efforts. However, the company also revealed the resignation of board member Josef Vejvoda.
Appili Therapeutics Inc. (TSX:APLI; OTCQX:APLIF) reported its second quarter results for FY 2022, ending September 30, 2021. The company experienced a net loss of $18.5 million, significantly higher than $5.1 million from the same period last year. Key updates include the enrollment of the last patient in the Phase 3 PRESECO trial for Avigan®/Reeqonus™ and strategic partnerships for future funding, such as a $3.5 million agreement with Lind Partners. The Company also announced management changes, with Kimberly Stephens leaving and Kenneth G. Howling stepping in as Acting CFO.
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.