Global expertise in establishing and executing transformative transactions which have led to multiple approved therapeutic products Successful track record across oncology therapeutics including ADCs and antibody therapies ranging from early discovery to pre-clinical/clinical stage 25+ year-career experience bolsters Company’s efforts to address growing, high-value ADC market and maximize opportunities for non-dilutive capital BOSTON and LONDON, May 01, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasd ...

Biotechnology and pharmaceutical industry veteran, Abizer Gaslightwala, shares his vision for Akari moving forward Access the video here BOSTON and LONDON, April 22, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing next-generation precision bi-functional antibody drug conjugates (ADC) for the treatment of cancer, today announced the release of a corporate update video featuring newly appointed President and Chief Executive Officer, Abizer Gaslightwala. The ...

Financial Performance - The net loss from operations for the year ended December 31, 2024, was approximately $21.6 million, an increase from approximately $16.8 million in 2023, primarily due to merger-related costs of $3.3 million and restructuring costs of $1.7 million[6]. - The company reported a net loss of $19.8 million for the year ended December 31, 2024, compared to a net loss of $10.0 million in 2023[19]. - Total operating expenses for 2024 were $21.6 million, compared to $16.8 million in 2023, reflecting the impact of merger-related expenses and increased R&D costs[19]. Research and Development - Research and development expenses for 2024 were reported at $7.0 million, compared to approximately $5.5 million in 2023, while general and administrative expenses decreased to approximately $9.7 million from $11.4 million[7]. - The lead candidate, AKTX-101, is a TROP2 PH1 ADC with a novel spliceosome inhibitor payload, showing superior activity and prolonged survival in preclinical models compared to existing ADCs[4]. - The company plans to continue advancing its pipeline by generating additional validating data on its PH1 payload while exploring new novel payloads PH5 and PH6[10]. Merger and Strategic Focus - Following the merger with Peak Bio, Inc. in November 2024, the company is focusing on the discovery and development of novel anti-cancer payloads that differ from currently approved ADC therapies[3]. - The company aims to secure development partners for its legacy pipeline assets to provide non-dilutive capital[5]. Financial Position - As of December 31, 2024, the company had cash of approximately $2.6 million, and with the net proceeds from a private placement of $6.6 million announced in March 2025, it is expected to fund operations into September 2025[8]. - The total assets as of December 31, 2024, were $50.6 million, significantly up from $4.4 million in 2023, primarily due to the merger[17].

Core Insights - Akari Therapeutics is advancing the development of next-generation precision bi-functional antibody drug conjugates (ADCs) to treat various cancer types, with a focus on its lead program, AKTX-101, for solid tumors [1][2][10] - The company has made strategic leadership appointments to enhance its capabilities and is well-positioned to capitalize on opportunities in the ADC space [2][3] - Akari's innovative platform technology allows for the generation of novel ADC candidates that aim to overcome limitations of existing therapies [3][5][10] Program Highlights - Following the merger with Peak Bio, Akari is concentrating on discovering and developing novel anti-cancer payloads with unique mechanisms of action [3] - The company is advancing a pipeline of potentially first-in-class ADC candidates designed to target and kill cancer cells while stimulating the immune system [3][5] Lead Candidate: AKTX-101 - AKTX-101 is a novel TROP2 PH1 ADC that utilizes a spliceosome inhibitor with multiple anti-tumor mechanisms [4][10] - Preclinical studies indicate that AKTX-101 has superior activity, prolonged survival, reduced resistance, and better tolerability compared to current ADCs [5][10] Financial Overview - For the fiscal year ended December 31, 2024, Akari reported a net loss from operations of approximately $21.6 million, an increase from $16.8 million in 2023, primarily due to merger-related costs and increased R&D expenses [7][8][19] - Research and development expenses were approximately $7.0 million for 2024, up from $5.5 million in 2023, while general and administrative expenses decreased to approximately $9.7 million from $11.4 million [8][19] - As of December 31, 2024, the company had cash of approximately $2.6 million, which, along with net proceeds from a private placement, is expected to fund operations into September 2025 [9][10] Legacy Pipeline Assets - The company is actively seeking development partners to secure non-dilutive capital for its legacy pipeline assets [6][10] Executive Team and Strategic Direction - Akari has made key leadership appointments to strengthen its executive team, including the appointment of Abizer Gaslightwala as President and CEO effective April 21, 2025 [2][13]

Product Development and Pipeline - The company is developing next-generation antibody-drug conjugates (ADCs) with novel payloads aimed at improving efficacy and safety in cancer therapies[19]. - The lead product candidate, AKTX-101, targets Trop2 and is in preclinical stage, focusing on solid tumors such as lung, breast, colon, and prostate cancers[26]. - The ADC platform includes additional candidates like AKTX-102, which targets a novel cancer antigen and is in discovery stage[27]. - The company aims to advance AKTX-101 to IND and initiate first-in-human trials, with a focus on maximizing commercial opportunities[29]. - The company is evaluating the first generation of PH5 linker-toxins against an undisclosed MMR/DDR target, which may enable bystander killing of neighboring cells[52]. - AKTX-101, the lead ADC product candidate, targets Trop2, which is upregulated in various malignant tumors, and has shown greater cytotoxicity at lower drug doses compared to a currently approved Trop2-targeting ADC[57][59]. - In preclinical studies, 50% of mice treated with AKTX-101 experienced tumor regression, compared to 20% for the currently approved Trop2 ADC[59]. - The proprietary L22 linker in AKTX-101 may provide a superior safety profile, demonstrating minimal killing of normal human fibroblasts compared to other Trop2-targeting ADCs[62]. - AKTX-101 was well-tolerated in a non-human primate model, with observed side effects resolving within weeks and no evidence of severe complications associated with other Trop2-targeting ADCs[63]. - The company has not initiated clinical studies for any of its active pipeline programs, which may delay commercialization for years[191]. - The company has not yet commenced or completed any clinical trials for its product candidates, indicating a high risk of failure in development[202]. Financial Performance and Capital Requirements - The company incurred net losses of $19.8 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $247.3 million as of December 31, 2024[178]. - The company has not commercialized any products or generated revenue from product sales, and expects to incur significant losses for the foreseeable future due to ongoing research and development activities[179]. - As of December 31, 2024, the company had cash of approximately $2.6 million and will require substantial additional capital to fund operations and product development[181]. - The company has cumulative net operating loss carryforwards of approximately $145.7 million in the UK, $38.1 million in the U.S. federal, and $71.8 million in various U.S. states, among others[187]. - The company may not have the financial resources to continue development of its product candidates if regulatory approvals are delayed or not obtained[194]. - The inability to complete development or significant delays in commercialization could materially adversely affect the company's business and financial condition[195]. - The development of pharmaceutical products is lengthy and expensive, with uncertain timelines and outcomes, which may delay commercialization[196]. Regulatory Environment and Compliance - The FDA regulates the drug approval process, requiring substantial time and financial resources for compliance[89]. - The NDA or BLA submission process involves a thorough review by the FDA, which may include additional information requests[98]. - The FDA may impose conditions on approval, such as a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the product[99]. - The FDA's review process assesses the safety, efficacy, and manufacturing compliance of the product before approval[100]. - The FDA may issue a complete response letter (CRL) requiring additional data for NDA or BLA approval[101]. - Standard review for an NDA takes ten months, while priority review can expedite this to six months for significant improvements in treatment[102]. - The Pediatric Research Equity Act mandates pediatric studies for most new drugs unless a deferral or waiver is granted[104]. - The Best Pharmaceuticals for Children Act provides a six-month exclusivity period for NDA holders if pediatric studies are completed[106]. - The Biologics Price Competition and Innovation Act grants a twelve-year exclusivity period for the first approved biological product[108]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained post-approval[120]. - The CT Regulation aims to streamline clinical trial approvals in the EU through a single-entry point and a centralized EU portal called the Clinical Trials Information System (CTIS)[125]. - The centralized authorization procedure allows for a single application to obtain marketing authorization valid in all EU Member States, mandatory for certain medicinal products[127]. - Conditional marketing authorizations can be granted prior to comprehensive clinical data if the product fulfills unmet medical needs and the risk-benefit balance is positive[132]. - The marketing authorization is valid for five years and can be renewed based on a re-evaluation of the risk-benefit balance[138]. - The Pediatric Investigation Plan (PIP) must be complied with before obtaining marketing authorization, covering all subsets of the pediatric population[135]. - The European Commission introduced legislative proposals in April 2023 to reform the regulatory framework for all medicines in the EU[151]. - Non-compliance with EU pharmacovigilance requirements can lead to significant financial penalties[144]. - The EMA's Committee for Medicinal Products for Human Use (CHMP) has 210 days to adopt an opinion on marketing authorization applications, which can be reduced to 150 days for accelerated assessments[129]. Strategic Focus and Partnerships - The company has suspended development of legacy programs nomacopan and PAS-nomacopan to focus on ADCs following the merger with Peak Bio, completed in November 2024[27]. - The strategy includes leveraging novel payloads and antibody-payload linkers for partnerships with biopharmaceutical companies[34]. - The company plans to out-license legacy non-oncology assets to raise capital for advancing ADC product candidates[34]. - The company may pursue opportunities to acquire or in-license additional businesses, technologies, or products[220]. - Strategic alliances or joint ventures may be formed to complement or augment the existing business[220]. Risks and Challenges - The biotechnology and pharmaceutical industries are characterized by rapid technological evolution and strong competition, impacting the company's ability to differentiate its products[71][73]. - The company faces risks if it cannot maintain and enforce its patent rights, which could allow competitors to develop similar technologies[84]. - There is no assurance that the company's patent applications will result in additional patents or that existing patents will provide sufficient protection against competitors[85]. - The company has issued composition-of-matter patents for nomacopan, but the validity of these patents could be challenged[86]. - Regulatory approvals are subject to significant variability, and the commercial success of approved products relies heavily on third-party payor coverage and reimbursement[197]. - The proprietary ADC Platform is based on unproven technologies, which may not lead to marketable products, exposing the company to unforeseen risks[217]. - Preclinical studies for the lead program AKTX-101 have only recently begun, with no clinical data generated yet, raising concerns about feasibility[218]. - Patient enrollment in clinical trials is influenced by various factors, including trial design and competing therapies, which may complicate timely completion[206]. - The company faces challenges in demonstrating safety and efficacy, which could result in additional costs and impair revenue generation from future product sales[210]. - The FDA's lack of experience in evaluating the company's product candidates may lead to longer regulatory review processes and increased development costs[219].

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]