Akari Therapeutics Plc - AKTX STOCK NEWS

Akari Therapeutics (Nasdaq: AKTX), a late-stage biotechnology firm focused on therapies for autoimmune diseases, will participate in the Cantor Oncology & HemOnc Conference on September 28, 2022. President and CEO Rachelle Jacques will address challenges in cell therapy during a panel at 9:00 a.m. Eastern time and will engage in 1:1 meetings with investors. Akari’s lead treatment, nomacopan, is under Phase 3 trials for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy, along with preclinical work on PAS-nomacopan for geographic atrophy.

Akari Therapeutics, Plc (Nasdaq: AKTX) announced a private placement for 15,000,000 American Depository Shares (ADSs) at $0.85 each, raising gross proceeds of approximately $12.75 million. The offering includes Series A and B Warrants, exercised at the same price with expiration dates in 2024 and 2029. Proceeds will fund Phase 3 trials for nomacopan targeting severe pediatric HSCT-TMA and a pre-clinical program for geographic atrophy. The closing of the offering is expected on September 14, 2022, pending customary conditions.

Akari Therapeutics (Nasdaq: AKTX) has announced a strategic shift to prioritize two key pipeline programs. The company will focus cash and resources on the Phase 3 clinical trial of nomacopan for severe pediatric HSCT-TMA, with initial data anticipated in H1 2023. Additionally, the promising pre-clinical program for PAS-nomacopan in geographic atrophy will receive attention following positive results. Conversely, Akari is discontinuing the clinical evaluation of nomacopan in bullous pemphigoid. This decision stems from a reassessment of timelines and costs to enhance pipeline value.

Akari Therapeutics (NASDAQ: AKTX) announced positive pre-clinical results for PAS-nomacopan aimed at treating geographic atrophy (GA) in dry age-related macular degeneration (dAMD), a condition with no current treatments. The studies highlighted tolerability and the potential for extended dosing intervals of over three months, which could ease patient burden. New pharmacokinetic measurements indicate improved half-life for the drug in the eye. CEO Rachelle Jacques emphasized the supportive data for advancing toward regulatory applications necessary for clinical trials by year-end.

Akari Therapeutics (NASDAQ: AKTX) recently announced significant progress in its clinical trials and financial results for Q1 2022. The Phase 3 Part A trial of nomacopan for severe pediatric HSCT thrombotic microangiopathy (TMA) has enrolled four out of seven planned patients. Additionally, ten sites have opened for the ARREST-BP Phase 3 trial in bullous pemphigoid (BP), aiming to enroll 48 patients. Financially, cash increased to approximately $16.7 million, with a net loss of $5.2 million. The company continues to advance pre-clinical programs for geographic atrophy in dAMD.

Akari Therapeutics (Nasdaq: AKTX) announced a patient has completed treatment in the Phase III clinical trial of nomacopan for pediatric HSCT-TMA, a serious post-stem cell transplant complication. Nomacopan, a bispecific inhibitor, shows promise as it is currently the only investigational therapy with Orphan Drug and Fast Track designations from the FDA. The trial aims to recruit seven pediatric patients in the U.S., U.K., and Poland. While one patient was discharged after over 60 days of treatment, another unfortunately died from unrelated complications. The mortality rate for severe HSCT-TMA is 80%. The study's primary endpoints focus on red blood cell transfusion independence and urine protein levels.

Akari Therapeutics, Plc (Nasdaq: AKTX) announced the appointment of Melissa Bradford-Klug as Chief Operating Officer, effective July 1, 2022. With over 25 years of experience across biotech and healthcare sectors, she will drive business development strategies and oversee the advancement of nomacopan, Akari's lead asset, targeting conditions like bullous pemphigoid. Bradford-Klug's appointment is expected to strengthen Akari's operational capabilities and accelerate clinical trials, enhancing the company's growth prospects and commitment to addressing unmet medical needs.

Akari Therapeutics (Nasdaq: AKTX) presented findings from its CASCADE and CORONET studies on COVID-19 pneumonia at the ATS 2022 Annual Meeting. The CASCADE study revealed elevated inflammatory biomarkers in COVID-19 pneumonia patients compared to healthy controls. The CORONET study demonstrated that 6 out of 7 hospitalized patients treated with the investigational drug nomacopan survived, showcasing its potential in reducing COVID-19 complications. No adverse effects were reported. The company focuses on therapies for autoimmune and inflammatory diseases, with nomacopan targeting complement activation.

Akari Therapeutics has initiated Phase III studies of nomacopan for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy and bullous pemphigoid, addressing critical unmet needs with no current approved treatments. The company's preclinical program for long-acting PAS-nomacopan shows promise in treating geographic atrophy/dry age-related macular degeneration. Financially, Akari reported a net loss of approximately $17.4 million for 2021, with cash reserves down to $9.4 million. The company increased manufacturing yield of nomacopan significantly, enhancing its development capabilities.