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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.
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Akari Therapeutics (Nasdaq: AKTX) announced presentations at the ARVO 2022 Annual Meeting focusing on innovative treatments for age-related macular degeneration (AMD) and allergic conjunctival disease. Professor Virginia Calder will present findings on topical nomacopan, a dual inhibitor, while Dr. Wynne Weston-Davies will discuss the long-acting PAS-nomacopan for retinal diseases. Both presentations highlight the unmet need for effective therapies targeting complement and leukotriene pathways in ocular conditions. The event will take place in Denver, CO, from May 1-2, 2022.
Akari Therapeutics (Nasdaq: AKTX) announced new preclinical data for votucalis, a novel broad-acting antihistamine, which shows promise in treating pain and itch linked to conditions like atopic dermatitis and psoriasis. The data, published in Frontiers in Pharmacology, highlight votucalis's ability to inhibit all four histamine GPCRs, offering new treatment avenues not available with current antihistamines. The research indicates votucalis achieves effective local administration at lower doses, potentially reducing CNS-related side effects typical of opioids.
Akari Therapeutics has secured approximately $9.0 million through definitive agreements with institutional and accredited investors, including Chairman Dr. Ray Prudo. The company will issue roughly 7,500,000 American Depository Shares (ADSs) at $1.20 per ADS, accompanied by warrants for additional shares. The offering is expected to close around March 10, 2022, pending customary conditions. This offering is registered under an effective shelf registration statement with the SEC, aiming to bolster Akari's financial position for development of its drug candidate, Nomacopan.
Akari Therapeutics has appointed Rachelle Jacques as President and CEO, effective end of March 2022. Jacques brings extensive experience in biotechnology, particularly in complement (C5) therapies, having previously served as CEO at Enzyvant Therapeutics and held significant roles at Alexion Pharmaceuticals. She is set to enhance the company's Phase 3 pipeline and drive commercialization efforts for nomacopan, a drug targeting rare diseases. Outgoing CEO Clive Richardson will support this transition.
Akari Therapeutics (Nasdaq: AKTX) announced promising results for its complement and leukotriene inhibitor, nomacopan, which improved survival rates in a preclinical trauma model from 30% to 80%. Funded by the U.S. Army's DoD, the findings suggest nomacopan's potential as a treatment for traumatic hemorrhage, addressing both military and civilian needs. The company plans further studies, including a collaboration for a UK observational study on traumatic brain injury. Nomacopan targets critical inflammatory pathways, making it viable for early intervention in severe trauma cases.
Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company, announced that CEO Clive Richardson will present at the BIO CEO & Investor Conference on February 15, 2022, at 2:30 p.m. ET in New York. The presentation will focus on Akari's innovative therapies targeting orphan autoimmune diseases and will be available live and on-demand for registered participants. The Company is developing Nomacopan, a C5 complement inhibitor, for conditions like bullous pemphigoid and thrombotic microangiopathy. Investors are encouraged to arrange meetings with management during the conference.
Akari Therapeutics (Nasdaq: AKTX) announced the development of an inhaled delivery system for its drug nomacopan, targeting orphan autoimmune and inflammatory diseases. Collaborating with Inhalation Sciences AB, Akari aims to enhance dosing and pharmacokinetics for both dry powder and nebulized forms. CEO Clive Richardson emphasized the potential of nomacopan in treating exacerbations in lung diseases like COPD and severe asthma by targeting complement C5 and leukotriene pathways. Observational studies show elevated levels of C5 and LTB4 in exacerbating conditions, supporting nomacopan's therapeutic potential.
Akari Therapeutics announced the FDA's approval of a new manufacturing process for its lead drug candidate, nomacopan, enhancing yield by at least 5-fold. This advancement significantly reduces the cost of goods for ongoing clinical studies and future commercialization. Nomacopan is currently in two Phase III clinical programs targeting conditions like bullous pemphigoid and thrombotic microangiopathy. This milestone marks a pivotal step towards bringing nomacopan to market, following years of development and collaboration with manufacturing partners.
Akari Therapeutics, Plc (Nasdaq: AKTX) announced that CEO Clive Richardson will present a company overview at the H.C. Wainwright BioConnect Conference, taking place virtually from January 10-13, 2022. The pre-recorded presentation will be accessible on-demand starting January 10, 2022, at 7:00 a.m. ET on the company’s website. Akari focuses on innovative therapeutics for rare autoimmune diseases, with its leading drug candidate Nomacopan targeting conditions influenced by complement and leukotriene systems.
Akari Therapeutics (Nasdaq: AKTX) announced a registered direct offering to raise approximately $6.0 million. The company will issue approximately 4,310,839 American Depository Shares (ADSs) at $1.40 per ADS, along with warrants for one-half ADS at an exercise price of $1.65. The offering is expected to close around January 4, 2022, pending customary conditions. Akari focuses on developing treatments for autoimmune and inflammatory diseases, with its lead drug candidate nomacopan currently in clinical evaluation for various conditions.
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