Core Viewpoint - Akari Therapeutics has appointed Abizer Gaslightwala as the new President and CEO, effective April 21, 2025, to lead the company in its next phase of growth in targeted oncology [1][2][3] Company Leadership Transition - Abizer Gaslightwala brings 25 years of experience in the biotechnology and pharmaceutical industry, previously serving as Senior Vice President and Franchise Head for US Oncology at Jazz Pharmaceuticals, overseeing a portfolio with annual sales of $1 billion [2][4] - Samir R. Patel, the current President and CEO, will remain on the Board of Directors after his tenure, during which he successfully oversaw the merger of Peak Bio and Akari [1][3] Strategic Direction - Under Gaslightwala's leadership, Akari aims to leverage its next-generation precision bi-functional antibody drug conjugates (ADCs) to develop breakthrough therapies for cancer patients [3][6] - The company’s lead candidate, AKTX-101, targets the TROP2 receptor and utilizes a novel PH1 payload designed to induce tumor-specific cell death while minimizing off-target toxicity [6] Product Development and Innovation - Akari's ADC platform is positioned to generate multiple novel candidates across various solid and hematological cancers, potentially overcoming limitations of current ADCs [6] - Preclinical studies of AKTX-101 have shown superior activity, prolonged survival, and better tolerability compared to traditional ADCs [6]

Core Viewpoint - Akari Therapeutics Plc has successfully priced a private placement financing round expected to raise approximately $7.6 million to invest in its ADC technology platform and seek license partners for its TROP-2 ADC program [1][2] Financing Details - The private placement involves the issuance of 6,637,626 unregistered American Depository Shares (ADSs) priced at $0.87 per ADS, with additional payments for warrants [2][4] - Gross cash proceeds from the offering are expected to be around $6.6 million before deducting fees and expenses [3] - The private placement is anticipated to close on or about March 5, 2025, subject to customary closing obligations [5] Company Overview - Akari Therapeutics is focused on developing next-generation precision bi-functional antibody drug conjugates (ADCs) for cancer treatment [8] - The lead candidate, AKTX-101, targets the TROP2 receptor and utilizes a novel PH1 payload designed to disrupt RNA splicing in cancer cells, potentially overcoming limitations of current ADCs [8][9] - Preclinical studies indicate that AKTX-101 has superior activity, prolonged survival, and better tolerability compared to existing ADCs [8][9]

Company Overview - Akari Therapeutics is a biotechnology company focused on developing next-generation precision bi-functional antibody drug conjugates (ADC) for cancer treatment [4] - The company utilizes an innovative ADC discovery platform to create novel bi-functional ADC candidates, optimizing them for various cancer applications [4] Lead Product Candidate - Akari's lead candidate, AKTX-101, targets the TROP2 receptor on cancer cells and employs a proprietary linker to deliver its novel PH1 payload directly into tumors [4] - PH1 is designed to disrupt RNA splicing within cancer cells, inducing tumor-specific cell death while minimizing off-target toxicity [4] - Preclinical studies indicate that AKTX-101 has superior activity, prolonged survival, and better tolerability compared to current ADCs [4] Synergistic Potential - AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival in preclinical models [4] - The company is generating validating data on its novel payloads to advance its pipeline [4] Investor Engagement - Akari Therapeutics participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CEO presented key reasons for investment consideration in 2025 [2][3]

Company Overview - Akari Therapeutics is a biotechnology company focused on developing next-generation precision bi-functional antibody drug conjugates (ADC) for cancer treatment [4] - The company utilizes an innovative ADC discovery platform to create novel bi-functional ADC candidates, optimizing them for various cancer applications [4] Lead Product Candidate - Akari's lead candidate, AKTX-101, targets the TROP2 receptor on cancer cells and employs a proprietary linker to deliver its novel PH1 payload directly into tumors [4] - PH1 is designed to disrupt RNA splicing within cancer cells, inducing tumor-specific cell death while minimizing off-target toxicity [4] - Preclinical studies indicate that AKTX-101 has superior activity, prolonged survival, and better tolerability compared to current ADCs [4] Synergistic Potential - AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival in preclinical models [4] - The company is generating validating data on its novel payloads to advance its pipeline [4] Investor Engagement - Akari Therapeutics participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CEO presented key reasons for investment consideration in 2025 [2][3]

Core Insights - Akari Therapeutics, Plc is a biotechnology company focused on developing next-generation precision bi-functional antibody drug conjugates (ADCs) for cancer treatment [2][7] - The company has launched a portal on the Webull Corporate Connect Service platform to enhance communication and transparency with shareholders and investors [3][4] Company Overview - Akari Therapeutics utilizes an innovative ADC discovery platform to create novel bi-functional ADC candidates aimed at targeting various cancers [7] - The lead candidate, AKTX-101, targets the TROP2 receptor on cancer cells and employs a proprietary linker to deliver a novel PH1 payload directly into tumors [7] - AKTX-101 is designed to induce tumor-specific cell death while minimizing off-target toxicity, potentially overcoming limitations of current ADCs [7] Product Development - In preclinical studies, AKTX-101 has demonstrated superior activity, prolonged survival, reduced resistance, and better tolerability compared to existing treatments [7] - The candidate has shown potential for synergy with checkpoint inhibitors and has resulted in prolonged survival in preclinical models [7] - The company is actively generating validating data on its novel payloads to advance its product pipeline [7] Communication Strategy - The addition of the Webull platform is part of the company's strategy to build market awareness and increase visibility among investors [4] - The platform will facilitate the release of corporate content, including news, earnings reports, and product updates [3][4]

Company Leadership Changes - Samir R. Patel, M.D. has been appointed as Chief Executive Officer of Akari Therapeutics, effective December 16, 2024, after serving as interim CEO since May 2024 [1][2] - Abizer Gaslightwala has been appointed to the Board of Directors, effective December 16, 2024, following the resignation of Michael Grissinger from the Board [1][7] Strategic Focus and Growth - Under Dr. Patel's leadership, the company successfully closed a merger with Peak Bio in November 2024 and is now focusing on streamlining operations and prioritizing its portfolio, particularly its antibody-drug conjugate (ADC) platform [2] - Dr. Patel expressed commitment to building momentum and driving shareholder value in both the near and long term [2] Leadership Background - Dr. Patel has over 20 years of experience in life sciences, including founding SPEC Pharma, LLC, and holding various roles in Medical Affairs at Centocor, Inc. [4] - Abizer Gaslightwala brings over 25 years of experience in the biotechnology and pharmaceutical industry, currently serving as Senior Vice President and Franchise Head for Oncology at Jazz Pharmaceuticals, overseeing a portfolio with total annual sales of $1 billion [6][8] Company Overview - Akari Therapeutics is a biotechnology company focused on developing advanced therapies for autoimmune, oncology, and inflammatory diseases, with lead assets including investigational nomacopan and an ADC platform [10][11]

Core Insights - Akari Therapeutics has appointed Torsten Hombeck, Ph.D. as Chief Financial Officer effective December 16, 2024, bringing over 20 years of experience in biotechnology, finance, and M&A transactions [1][2][3] - Dr. Hombeck previously served as CFO of Akari from 2019 to June 2023, where he raised over $50 million, and has a strong background in clinical development and commercial expertise [3][4] - The company is focused on advancing its first-in-class antibody-drug conjugate (ADC) platform and believes there is significant potential to drive shareholder value [3][5] Company Overview - Akari Therapeutics is a biotechnology company developing therapies for autoimmune, oncology, and inflammatory diseases, with lead assets including investigational nomacopan and an ADC platform [5] - Nomacopan is a bispecific recombinant inhibitor targeting complement C5 activation and leukotriene B4 activity, currently undergoing pre-clinical research for geographic atrophy [5]

Financial Performance - The company reported a loss from operations of $2.9 million for the three months ended September 30, 2024, a 17% increase from a loss of $2.5 million in the same period of 2023[176]. - For the nine months ended September 30, 2024, the loss from operations totaled $16.4 million, a 40% increase compared to a loss of $11.7 million for the same period in 2023[176]. - Net loss applicable to ordinary shareholders for the three months ended September 30, 2024, was $2.9 million, and for the nine months ended September 30, 2024, it was $16.0 million, compared to $5.9 million for the same period in 2023[200]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $2.9 million, up 17% from $2.5 million in the same period of 2023[176]. - Research and development expenses increased by approximately $0.5 million, or 146%, for the three months ended September 30, 2024, compared to the same period in 2023[178]. - Total research and development expenses for the nine months ended September 30, 2024, were $5.7 million, a 95% increase from $2.9 million in the same period of 2023[178]. - Personnel costs decreased by $0.5 million, or 60%, for the three months ended September 30, 2024, and by $1.2 million, or 48%, for the nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to the impact of the RIF announced in May 2024[184]. - General and administrative expenses decreased by approximately $1.1 million, or 39%, for the three months ended September 30, 2024, and by approximately $2.2 million, or 25%, for the nine months ended September 30, 2024, compared to the same periods in 2023[187]. - Merger-related costs for the three and nine months ended September 30, 2024, were $1.0 million and $2.3 million, respectively, with no such costs incurred during the corresponding 2023 periods[188]. - Restructuring and other costs for the three and nine months ended September 30, 2024, were $0.1 million and $1.7 million, respectively, including $0.3 million of non-cash share-based compensation expense for the nine months ended September 30, 2024[190]. Cash Position and Funding - As of September 30, 2024, the company had $2.2 million in cash and an accumulated deficit of $243.5 million, with no revenue generated to date[202]. - The company expects existing cash, plus cash from the November 2024 Private Placement, to fund operations into the first quarter of 2025[211]. - In November 2024, the company agreed to sell and issue 1,713,402 ADSs and warrants for aggregate gross proceeds of $3.2 million[207]. - In May 2024, the company raised approximately $7.6 million from a private placement of 4,029,754 ADSs and warrants[208]. - The company may need to raise additional funds and is exploring various financing options, including equity and debt securities[204]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $10,428 thousand, compared to $12,023 thousand for the same period in 2023[219]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $8,834 thousand, an increase from $3,503 thousand in the same period of 2023[221]. - The company reported a net decrease in cash of $1,599 thousand for the nine months ended September 30, 2024, compared to a decrease of $8,519 thousand in 2023[219]. - The company has substantial doubt regarding its ability to continue as a going concern within one year after the issuance of its unaudited condensed consolidated financial statements[217]. - The company is facing challenges in obtaining funding due to market receptivity and integration of operations following a merger[216]. - The company’s cash position may be adversely impacted by increases in expenses or delays in clinical development[216]. Operational Changes - The company implemented a reduction-in-force of approximately 67% of its total workforce as part of an operational restructuring plan[172]. - The HSCT-TMA program was suspended in May 2024 due to a portfolio prioritization review, impacting clinical trial costs[169][172]. - The merger with Peak Bio was completed on November 14, 2024, expanding the company's pipeline with new assets and technologies[173]. Regulatory and Development Plans - The company plans to file an Investigational New Drug Application (IND) with the FDA in 2025 for PAS-nomacopan, a long-acting form of nomacopan[168]. Accounting Policies - The company has not experienced material changes to its critical accounting policies and estimates since December 31, 2023[226]. - The company is a smaller reporting company and is not required to provide certain market risk disclosures[227].

Company Overview - Akari Therapeutics, Plc has completed a merger with Peak Bio, Inc, creating a biotechnology company focused on advancing multiple disease therapies, particularly in Antibody Drug Conjugates (ADCs) and treatments for autoimmune and inflammatory diseases, including Geographic Atrophy (GA) [1][2] Financing Details - The company secured $3.2 million in PIPE financing and obtained a $50 million term sheet for an equity line of credit (ELOC) [1][6] - A definitive agreement for a private placement financing was entered into on November 13, 2024, involving the sale of 1,713,402 unregistered American Depository Shares (ADSs) at a price of $1.70 for most investors and $2.385 for insiders [3] - The warrants associated with this financing have a term of 3 years and an exercise price of $2.26 per ADS [3] Strategic Focus - The company plans to execute its strategy with a specific focus on ADC and GA milestones over the next 12 months, leveraging immediate capital from PIPE financing and the ELOC [2] - The incoming Chairman, Hoyoung Huh, emphasized the goal of driving shareholder value and seeking new opportunities in oncology, autoimmune, and inflammatory diseases [2] Future Outlook - The private placement is expected to close shortly after the merger, subject to customary closing obligations [4] - The ELOC allows the company to sell up to $50 million of newly issued ADSs over a 3-year period, providing flexibility in funding based on market conditions and company operations [6][7] Company Background - Akari Therapeutics is developing advanced therapies for autoimmune and inflammatory diseases, with its lead asset being investigational nomacopan, a bispecific recombinant inhibitor targeting complement C5 activation and leukotriene B4 activity [8]

BOSTON and LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an innovative biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, announces shareholder approval in connection with the merger of Akari Therapeutics, Plc (the Company) and Peak Bio, Inc. At a General Meeting held in relation to the merger at 9:00 a.m. Eastern Time on Thursday, November 7, 2024 at the Company’s offices in London, shareholders approved the Company’s issuance o ...