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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) has announced two key leadership appointments. Samir R. Patel, M.D., who has served as interim CEO since May 2024, has been appointed permanent Chief Executive Officer effective December 16, 2024. Additionally, Abizer Gaslightwala, a biotechnology industry veteran with over 25 years of experience, has joined the Board of Directors, while Michael Grissinger has resigned.
Dr. Patel highlighted the company's recent merger with Peak Bio and emphasized their focus on streamlining operations and executing their ADC platform strategy. Gaslightwala brings extensive experience from his current role as Senior Vice President and Franchise Head for Oncology at Jazz Pharmaceuticals, where he manages a $1B portfolio including products like ZIIHERA®, ZEPZELCA®, and RYLAZE®.
Akari Therapeutics (Nasdaq: AKTX) has appointed Torsten Hombeck, Ph.D. as Chief Financial Officer, effective December 16, 2024. Dr. Hombeck, who previously served as Akari's CFO from 2019 to June 2023, brings over 20 years of biotechnology industry experience. During his previous tenure at Akari, he successfully raised over $50 million. Before rejoining Akari, he served as CFO at Aspira Women's Health. His extensive experience includes roles as Chief Commercial and Strategy Officer at Promethera Biosciences and Co-CEO at Cytonet. The appointment aims to strengthen the company's leadership team as it focuses on advancing its first-in-class ADC platform.
Akari Therapeutics (NASDAQ: AKTX) has successfully resolved its shareholders equity deficiency issue and regained full compliance with Nasdaq listing requirements. The company received written confirmation from Nasdaq's Listing Qualifications Staff that its deficiency under Listing Rule 5550(b) has been cured. As a result, the previously scheduled Nasdaq hearing before the Hearings Panel on November 21 has been cancelled, and AKTX will continue trading on the Nasdaq Capital Market.
Akari Therapeutics announces the completion of its merger with Peak Bio, creating a biotechnology company focused on developing Antibody Drug Conjugates and therapies for autoimmune and inflammatory diseases. The merger includes a $3.2m PIPE financing and a $50m term sheet for an Equity Line of Credit. The company sold 1,713,402 unregistered American Depository Shares at $1.70 per unit (non-insiders) and $2.385 (insiders), along with Series C Warrants. The warrants have a 3-year term and an exercise price of $2.26 per ADS. The ELOC with White Lion Capital provides the right to sell up to $50m of newly issued ADSs over 3 years.
Akari Therapeutics (Nasdaq: AKTX) announces shareholder approval for its merger with Peak Bio, Inc. At the General Meeting held on November 7, 2024, approximately 99% of shareholders voted in favor of the merger-related share issuance. The transaction is expected to close on November 13, 2024. The combined entity will focus on Antibody Drug Conjugate (ADC) and Geography Atrophy (GA) platforms. Upon merger completion, the company expects to resolve its Nasdaq shareholder deficiency issue, eliminating current listing risks.
Akari Therapeutics (Nasdaq: AKTX) has announced the effectiveness of its Form S-4, filed on September 13, 2024, related to the merger with Peak Bio. The SEC declared the form effective on October 11, 2024, allowing Akari to schedule the General Meeting for November 7, 2024, at 9:00 a.m. Eastern Time in London.
Samir Patel, MD, Akari's Interim President & CEO, expressed excitement about the merger's progress. He highlighted the company's plans to focus on Antibody Drug Conjugate (ADC) and Geography Atrophy (GA) platforms post-merger. Patel also noted that, pending shareholder approval, the merger could help Akari address its Nasdaq shareholder deficiency issue.
Akari Therapeutics (Nasdaq: AKTX) has appointed Rob Bazemore, an experienced life sciences leader, to its Board of Directors effective September 17, 2024. Mr. Bazemore brings over 30 years of experience in developing and commercializing novel medicines, including roles as President, CEO, and COO in various pharmaceutical and biotech companies.
His expertise spans multiple therapeutic areas, including immunology, autoimmune diseases, and oncology. Notably, Mr. Bazemore served as President and CEO of Epizyme, Inc. from 2015 to 2021, where he led the development and launch of TAZVERIK® for Follicular Lymphoma and Sarcoma. He also held leadership positions at Synageva BioPharma Corp., Johnson & Johnson, and Merck & Co. Inc.
Akari's Chairman, Ray Prudo, M.D., expressed confidence that Mr. Bazemore's strategic and management expertise will be invaluable in advancing the company's portfolio, particularly its lead asset, nomacopan, and Peak's innovative antibody-drug-conjugate (ADC) platform in oncology.
Akari Therapeutics (NASDAQ: AKTX) reported Q2 2024 financial results and recent highlights. Key points:
- Appointed Samir R. Patel as Interim CEO
- Prioritized PAS-nomacopan for Geographic Atrophy
- Received positive FDA Pre-IND feedback for PAS-nomacopan
- Raised $7.6 million in upsized financing
- Issued $1 million in convertible notes to existing investors
Financial results: Cash of $4.2 million as of June 30, 2024. Q2 R&D expenses increased to $3.3 million, while G&A expenses decreased to $2.2 million. Net loss widened to $7.6 million for Q2 2024. The company plans to file an IND for PAS-nomacopan in Geographic Atrophy in 2025 and is progressing with its merger with Peak Bio.
Akari Therapeutics (AKTX) has received positive Pre-IND feedback from the FDA for PAS-nomacopan, a long-acting bispecific inhibitor of C5 and LTB4 for treating geographic atrophy (GA). The feedback provides clarity on preclinical plans, drug manufacturing, and Phase 1 clinical strategy. PAS-nomacopan potentially offers longer dose intervals between intravitreal injections and reduced choroidal neovascularization (CNV) risk compared to current complement inhibitors. A GMP-compliant batch of drug substance has been manufactured by Wacker Biotech GmbH for IND-enabling studies and initial clinical development. Akari plans to submit the IND in 2025, paving the way for Phase 1 clinical studies in GA treatment.
Akari Therapeutics announced that interim CEO Samir R. Patel, M.D., will receive compensation solely through equity, aligning his interests directly with shareholders. Dr. Patel has increased his ownership in Akari to 14.2% with a $1.25 million investment in a recent private placement. This move underscores Dr. Patel's commitment to shareholder value and transparency. The company is focused on advancing its lead compound, nomacopan, and completing a merger with Peak Bio. Dr. Patel has a strong background in the life sciences sector and has held various leadership roles. Related details are available in the Form 8-K and Form 4 filed on June 4, 2024.
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