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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) 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.
Akari Therapeutics (Nasdaq: AKTX) announced a successful initial closing of a private placement financing round, raising approximately $7.6 million in gross proceeds. The financing garnered strong support from both new and existing investors, highlighted by Akari's Chairman, Dr. Ray Prudo, and Interim President and CEO, Dr. Samir R. Patel. The funds will support Akari's strategic initiatives, including their upcoming merger with Peak Bio, expected to close in Q3 2024. The financing involved the sale of 4,029,754 unregistered ADSs and Series C Warrants to purchase an equal number of ADSs at $1.885 per unit. The warrants have a three-year term and cashless exercise provisions, with different exercise prices for company executives and other investors.
Akari Therapeutics (Nasdaq: AKTX), a late-stage biotechnology firm, reported its first-quarter 2024 financial results, announcing a net loss of $5.6 million and highlighting recent activities. The company entered into a definitive merger agreement with Peak Bio, anticipated to close in Q3 2024. The combined entity will prioritize Peak's ADC cancer therapeutic platform and Akari's PAS-nomacopan for Geographic Atrophy. A restructuring plan has commenced, reducing the workforce by 67% to cut operating costs. Akari issued $1 million in unsecured convertible notes to secure operational capital. Research and development expenses rose to $2.3 million, while general and administrative costs increased to $3.7 million, compared to the same period in 2023.
Summary: Akari Therapeutics, Plc announced the appointment of Samir R. Patel, M.D. as interim CEO, replacing Rachelle Jacques. Dr. Patel aims to complete the merger with Peak Bio, prioritize the company's portfolio, and advance its lead compound, nomacopan. The leadership changes are expected to bring cost savings through reduced clinical trial and infrastructure expenses.
Akari Therapeutics and Peak Bio have announced a joint portfolio prioritization plan following their merger, focusing on Peak's ADC cancer therapeutic platform technology and Akari's PAS-nomacopan for Geographic Atrophy. The companies aim to secure business development opportunities and funding while advancing these key programs.
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