Appili Ther Stock Price, News & Analysis

Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced that Stéphane Paquette, Vice President of Corporate Development, will present at the Bloom Burton & Co. Healthcare Investor Conference on May 3, 2022. The presentation will focus on updates regarding Appili's pipeline of novel anti-infectives, including the biodefense vaccine candidate ATI-1701 and the clinical program for ATI-1801, aimed at treating cutaneous leishmaniasis. The conference takes place at the Metro Toronto Convention Centre.

Appili Therapeutics (OTCQX: APLIF) announced the addition of ATI-1801, a topical treatment for cutaneous leishmaniasis, to its pipeline. This drug, already proven safe and effective in a Phase 3 study, offers an outpatient alternative to current invasive treatments. With a significant clinical cure rate (82% vs 58%; p < 0.001), ATI-1801 is set for FDA discussions later this year for a new drug application. Appili aims to secure funding and partnerships to complete development, and believes ATI-1801 may qualify for a priority review voucher, potentially enhancing its market value.

Appili Therapeutics (TSX: APLI; OTCQX: APLIF) has secured a US$3.6 million senior loan from Long Zone Holdings Inc. to retire existing funding and for operational needs. The loan, with an 8.5% annual interest rate, has a maturity date of March 28, 2025. Appili will receive about US$3.5 million post-fees and grant LZH exclusive rights to market its products in Canada, Israel, and Latin America, excluding ATI-1501. Additionally, Appili is set to receive more than US$10 million from the US Department of Defense, enhancing its pipeline development.

Appili Therapeutics Inc. (OTCQX: APLIF) has secured over US$10 million in funding from the U.S. Department of Defense to advance its biodefense vaccine candidate ATI-1701 against Francisella tularensis, a top biothreat. This funding, expanding upon a prior contract, supports comprehensive development including regulatory activities for an IND submission to the FDA. Recent preclinical results showcased promising survival rates in vaccinated cohorts, positioning ATI-1701 as a potential first-in-class vaccine for tularemia.

Appili Therapeutics reported significant advancements in Q3 2022, focusing on expanding its portfolio for infectious diseases. A new commercial agreement with Saptalis will broaden access to its antibiotic ATI-1501 globally. The company announced positive preclinical results for its vaccine candidate ATI-1701 against biothreats. However, a net loss increased to $21.7 million, up $12.4 million from the previous year due to rising R&D costs. Cash reserves fell to $9.4 million as of December 31, 2021, compared to $16.1 million earlier in 2021.

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.