Core Viewpoint - Akari Therapeutics has made significant progress in 2025 towards developing best-in-class antibody drug conjugates (ADCs) with a novel payload, positioning the company for a pivotal year ahead in 2026 [1][12]. Group 1: Scientific Advancements - Akari has established a clear scientific roadmap focused on its proprietary PH1 payload, which is designed to overcome limitations of existing ADC payloads by directly killing cancer cells and engaging the immune system [2][4]. - The lead program, AKTX-101, is a Trop2 targeted ADC that utilizes the PH1 payload and has shown significant preclinical activity against various cancers, including pancreatic and prostate cancers [6][17]. - The partnership with WuXi XDC for GMP-grade clinical product manufacturing is a critical milestone that supports the upcoming Phase 1 clinical trials for AKTX-101 [4][7]. Group 2: Intellectual Property and Engagement - Akari has strengthened its intellectual property portfolio with new provisional patent filings related to the PH1 payload, enhancing the value of its ADC platform [8]. - Promising immuno-oncology data was presented at the Society for Immunotherapy Cancer (SITC), generating enthusiasm among researchers and scientists regarding the unique approach of splicing modulation via the PH1 payload [9]. Group 3: Operational and Financial Strategy - The company has taken steps to strengthen its operating model and capital discipline, enabling R&D milestones and key patent filings while reducing operating expenses post-merger [11]. - Akari is positioned to pursue additional financing and partnership opportunities with strategic investors and pharmaceutical companies, leveraging upcoming catalysts and milestones with AKTX-101 [11]. Group 4: Future Outlook - 2026 is anticipated to be a transformational year for Akari, with key milestones including the initiation of Phase 1 clinical studies, regulatory interactions with the FDA, and continued partnership discussions [12][15]. - The transition from a preclinical discovery company to a clinical-focused biotechnology player is expected to enhance visibility and investor interest [13][14].

Akari Will Exclusively Partner With Industry Leader WuXi XDC For This Key IND-enabling WorkTAMPA, Fla. and LONDON, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, today announced the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program. Akari has selected WuXi XDC, the world’s leading ADC contract development and manufacturin ...

Core Insights - Akari Therapeutics is advancing a new class of immuno-oncology antibody drug conjugates (ADCs) utilizing a novel PH1 payload designed to target and disrupt the spliceosome, showing promising preclinical efficacy and safety profiles [3][4] - The lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and is set to enter IND-enabling studies with plans for clinical trials in Q4 2026 [3][4] Company Overview - Akari Therapeutics specializes in developing next-generation spliceosome payload ADCs, differentiating itself from traditional ADCs that use tubulin inhibitors and DNA damaging agents [4] - The PH1 payload is a spliceosome modulator that disrupts RNA splicing in cancer cells, leading to cancer cell death and activation of immune responses [4] Product Development - AKTX-101 has demonstrated significant activity and prolonged survival in preclinical studies compared to traditional ADCs, with potential for synergy with checkpoint inhibitors [4] - The company is generating validating data on the PH1 payload to advance AKTX-101 and explore other undisclosed targets [4]

Core Insights - The novel spliceosome targeting payload, PH1, shows potential in inducing cancer cell cytotoxicity and activating anti-tumor immunity through various mechanisms [1][3] - The combination of Trastuzumab-PH1 ADC with anti-PD1 therapy significantly outperforms Kadcyla® with anti-PD1 in achieving complete tumor regressions (74% vs. 42%, p<0.05) [1][12] - Akari Therapeutics is advancing its lead ADC candidate, AKTX-101, which targets the Trop2 receptor and utilizes the PH1 payload, aiming to enter clinical trials soon [7][9] Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [9] - The company’s innovative ADC platform allows for the generation and optimization of ADC candidates tailored to specific targets [9] - The PH1 payload is designed to disrupt RNA splicing in cancer cells, leading to cancer cell death and immune activation [9] Mechanism of Action - Trastuzumab-PH1 induces RNA mis-splicing, resulting in increased neoantigen generation and a subsequent rise in anti-cancer immune cells within the tumor microenvironment [4][12] - The combination therapy enhances immune responses, including the polarization of macrophages, increase in neutrophils, and expansion of B cell clones producing IgM antibodies [3][12] - The synergy between Trastuzumab PH1 and anti-PD1 therapy is attributed to their complementary effects on the immune system, particularly the expansion of gamma-delta T cell clones [3][12] Market Potential - The immuno-oncology therapeutic class is currently valued at approximately $50 billion per year, with the potential for significant growth through innovative therapies like those developed by Akari [1][4] - The unique results from the Trastuzumab-PH1 and anti-PD1 combination therapy could establish a new standard of care in cancer treatment, improving patient outcomes [6][12] Upcoming Events - Akari Therapeutics will host a live webcast on November 18, 2025, to discuss the presented data, providing insights for investors and analysts [1][8]

Core Points - Akari Therapeutics has entered into a definitive agreement for the issuance and sale of 3,125,000 American Depositary Shares (ADSs) at a price of $0.80 per ADS in a registered direct offering [1] - The gross proceeds from the offering are expected to be approximately $2.5 million, which will be used for working capital, general corporate purposes, and continued research and development [4] Offering Details - Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering [2] - The company will also issue unregistered Series E and Series F Warrants to purchase up to 3,125,000 ADSs at an exercise price of $0.98 per share [3] - The offering is expected to close on or about October 16, 2025, subject to customary closing conditions [3] Research and Development Focus - The funds from the offering will be used to generate differentiated data on the novel ADC payload, which targets cancer cells and aims to highlight its unique action against cancer [4] - Akari's lead candidate, AKTX-101, utilizes a novel spliceosome modulator payload designed to disrupt RNA splicing within cancer cells, showing significant activity in preclinical studies [8][9] Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [8] - The company aims to advance its lead asset, AKTX-101, and other undisclosed targets with its novel payload [9]

Core Insights - Akari Therapeutics has filed a provisional patent application for its antibody drug conjugate (ADC) platform utilizing the spliceosome payload PH1 for cancer treatment, aiming to enhance its proprietary position in the oncology sector [1][2][4] Company Developments - The provisional patent application expands Akari's intellectual property estate and is based on the advances in understanding spliceosome modulation, which could lead to differentiated clinical outcomes for cancer patients [2][4] - Akari's lead candidate, AKTX-101, targets the Trop2 receptor and utilizes the PH1 payload, which is designed to disrupt RNA splicing in cancer cells, showing significant activity and prolonged survival in preclinical studies compared to traditional ADCs [5] Industry Context - Alternative splicing (AS) is a process that cancer cells exploit to produce protein isoforms that support tumor growth and survival, making it a critical target for cancer therapies [3] - Disrupting AS is seen as a fundamental approach to targeting various cancers, including those driven by specific spliced variants, thus positioning Akari to potentially lead in developing therapies against a wide range of cancers [3]