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Akari Therapeutics Plc (Nasdaq: AKTX) is a clinical-stage biopharmaceutical company developing innovative treatments for autoimmune and inflammatory diseases. The company's lead asset, nomacopan, is a bispecific recombinant inhibitor targeting complement C5 and leukotriene B4 (LTB4) pathways. This dual-action therapeutic is currently being investigated in a Phase 3 trial for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), a rare and serious complication with high mortality rates. Nomacopan has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA, as well as orphan drug designation from the European Commission.
Akari's pipeline also includes PAS-nomacopan, a long-acting version of the drug designed for the treatment of geographic atrophy (GA), a leading cause of blindness. PAS-nomacopan is in the final stages of pre-clinical development and aims to offer extended dosing intervals with potentially improved safety and efficacy compared to existing therapies.
The company's strategic focus recently expanded through a definitive merger agreement with Peak Bio Inc. (OTC: PKBO), expected to close in Q3 2024. This merger will create a robust pipeline featuring both Akari's autoimmune and inflammatory disease therapeutics and Peak Bio's antibody-drug conjugate (ADC) platform technology for cancer treatment.
Financially, Akari is focused on operational efficiency and value creation. The company has taken significant measures to reduce costs and secure funding, including a successful private placement raising approximately $7.6 million. Dr. Samir R. Patel, an experienced life sciences entrepreneur, has recently been appointed Interim CEO to lead the company through this transformative phase. Dr. Patel's compensation is solely equity-based, aligning his interests with those of the shareholders.
For more information, visit akaritx.com.
Akari Therapeutics (NASDAQ: AKTX) reported progress in its clinical programs for nomacopan, focusing on treatments for severe autoimmune conditions, including bullous pemphigoid and pediatric HSCT-TMA. The Phase III studies are now enrolling patients, with FDA designations as Orphan Drug and Fast Track. Financially, as of September 30, 2021, the company had $13.4 million in cash and reported a net loss of approximately $1.5 million for Q3 2021, compared to a net income of around $0.9 million in Q3 2020. R&D income also declined significantly to $0.4 million.
Akari Therapeutics (Nasdaq: AKTX) announces findings suggesting the therapeutic potential of nomacopan in managing exacerbations related to severe lung conditions like COPD and COVID pneumonia. Data from observational studies indicate elevated levels of inflammatory mediators C5a, C5b9, and LTB4 in patients, correlating with disease severity. The increasing evidence highlights nomacopan's ability to inhibit these mediators, potentially aiding in disease progression prevention. Akari is pursuing further clinical evaluation of inhaled nomacopan's pharmacokinetics in exacerbating patients.
Akari Therapeutics (AKTX) announces Professor Tim Higenbottam will present at the 5th Annual Complement-based Drug Development Summit from October 26-28, 2021. His presentation, titled 'Clinical Impacts of Controlling Dysregulation of the Terminal Complement Pathway and LTB4,' will focus on complement dysregulation in various diseases, insights from COVID-19, and the implications for treating these conditions with Akari’s lead candidate, Nomacopan. The presentation is scheduled for October 28 at 3:00 p.m. ET, and after, it will be accessible on Akari's website.
Akari Therapeutics (Nasdaq: AKTX) announced promising results from its study on nomacopan eyedrops, which demonstrated greater efficacy in reducing inflammation compared to cyclosporin and dexamethasone in allergic eye disease models. The study found a 79% reduction in inflammation with nomacopan versus 41% and 73% for the other treatments, respectively. This data supports nomacopan's potential in treating severe eye conditions. Akari is also advancing its programs in related ocular diseases and collaborating on topical treatments for mucous membrane pemphigoid.
Akari Therapeutics, Plc (Nasdaq: AKTX) announced that CEO Clive Richardson will present at the Cantor Virtual Global Healthcare Conference on September 30, 2021, at 1:20 p.m. ET. Investors can schedule virtual meetings with management via the conference coordinator. A webcast of the presentation will be available on the company’s website, with a replay accessible for 90 days. Akari focuses on developing innovative treatments for orphan autoimmune diseases, with its lead candidate, nomacopan, being evaluated in multiple clinical areas.
Akari Therapeutics, Plc (Nasdaq: AKTX) is advancing its clinical pipeline with two Phase III studies for nomacopan, targeting bullous pemphigoid and severe pediatric HSCT-TMA. Both programs have received Orphan Drug and Fast Track designations from the FDA. Recent financial results show a cash position reduced to $3.8 million as of June 30, 2021, improved net loss at $4.3 million, and operational cost reductions. The company is also pursuing various other programs in ophthalmology and lung diseases, leveraging partnerships to enhance drug development.
On September 10, 2021, Akari Therapeutics (Nasdaq: AKTX) announced that Dr. Miles Nunn and Dr. Sanjeev Khindri will present a poster on the Phase III study design of nomacopan for treating moderate to severe bullous pemphigoid (BP) at the 2021 IPPF Scientific Symposium. The trial aims to evaluate nomacopan's safety and its capacity to control BP symptoms while reducing reliance on systemic steroids. The presentation is scheduled for September 20, 2021. Akari focuses on innovative therapeutics for orphan autoimmune diseases and has identified significant potential for nomacopan as a targeted therapy.
Akari Therapeutics, Plc (Nasdaq: AKTX) announced that CEO Clive Richardson will present at the H.C. Wainwright 23rd Annual Global Investment Conference, held virtually from September 13-15, 2021. The presentation will highlight Akari's focus on innovative therapies for orphan autoimmune and inflammatory diseases, particularly its lead drug candidate, Nomacopan, a dual C5 complement and leukotriene B4 inhibitor. Investors can access the webcast on-demand starting September 13, 2021, at 7:00 a.m. ET on the Akari website.
Akari Therapeutics (Nasdaq: AKTX) has announced a private placement of equity securities, aiming to raise approximately $12 million. This funding will be achieved through the issuance of unregistered American Depository Shares (ADSs) at $1.55 each, representing 100 ordinary shares. The offering's closing is expected by the week of July 12, 2021, pending standard closing conditions. Paulson Investment Company is acting as the exclusive placement agent. Akari focuses on innovative therapeutics for orphan autoimmune diseases, with its lead candidate, Nomacopan, in clinical evaluation for multiple conditions.
Akari Therapeutics has opened an Investigational New Drug (IND) application with the FDA for a Phase III study of nomacopan targeting bullous pemphigoid and pediatric HSCT-TMA. The company reported a net loss of approximately $5.8 million for Q1 2021, higher than last year's $3.7 million. Cash reserves decreased to $6.7 million. The ongoing development of nomacopan also includes potential treatments for dry age-related macular degeneration and various lung diseases. Akari’s operational team is expanding as part of its strategy to advance its clinical programs.
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