Company expands its ADC pipeline and patent estate for novel, differentiated ADCs New pipeline candidate AKTX-102 leverages Akari’s proprietary PH1 spliceosome payload and a novel antibody construct to address one of oncology’s most challenging and valuable solid tumor targets, CEACAM5 TAMPA and LONDON, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, ...

As filed with the Securities and Exchange Commission on January 23, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AKARI THERAPEUTICS, PLC (Exact name of registrant as specified in its charter) England and Wales 2834 98-1034922 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code) (I.R.S. Employer Identification No.) 401 East Jackson ...

Core Insights - Akari Therapeutics is progressing towards becoming a clinical-stage oncology company in 2026, with significant milestones achieved in 2025 [3][4] - The company is developing a novel payload, PH1, for its antibody-drug conjugates (ADCs), which has shown promising preclinical efficacy and safety [4][6] - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and has demonstrated significant activity and prolonged survival in preclinical studies [6] Company Developments - In 2025, Akari established a strategic manufacturing partnership with WuXi Biologics to support clinical readiness [4] - The company plans to initiate its First-in-Human clinical trial for AKTX-101 by late 2026 or early 2027 [6] - Akari is also advancing another ADC candidate, AKTX-102, targeting a novel antigen relevant in gastrointestinal and lung cancers [6] Scientific Innovations - The PH1 payload is designed to disrupt RNA splicing within cancer cells, leading to cancer cell death while activating the immune system [6] - AKTX-101 has the potential for synergy with checkpoint inhibitors, showing prolonged survival both as a single agent and in combination therapies [6] - The PH1 payload has demonstrated activity against cancer cells with key oncogenic drivers such as KRAS, BRAF, and ARV7 [6]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation antibody drug conjugates (ADCs) with a unique payload, PH1, which targets RNA splicing [3] - The company's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and utilizes a proprietary linker to deliver the PH1 payload directly into tumors with minimal off-target effects [3] - AKTX-101 has shown significant activity and prolonged survival in preclinical studies compared to traditional ADCs, and it has the potential to be synergistic with checkpoint inhibitors [3] Strategic Priorities - Akari Therapeutics aims to initiate IND enabling studies for AKTX-101, with a goal of starting its First-In-Human trial by late 2026 or early 2027 [3] - The company is also advancing AKTX-102, an ADC targeting a novel antigen relevant in gastrointestinal and lung cancers [3] Upcoming Presentation - Abizer Gaslightwala, President and CEO of Akari Therapeutics, will present at the 2026 Biotech Showcase on January 13, 2026, at 9:30 AM PST [1][2] - The presentation will cover an overview of Akari's ADC platform, strategic priorities, and key milestones for 2026 [1]

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].

Core Viewpoint - Akari Therapeutics has initiated GMP manufacturing activities for its lead ADC program, AKTX-101, in partnership with WuXi XDC, aiming to support clinical trials and advance cancer treatment options [1][2][4]. Group 1: Partnership and Manufacturing - Akari has selected WuXi XDC, a leading ADC contract development and manufacturing organization, for critical IND-enabling work to support clinical trials [2][4]. - The collaboration aims to leverage WuXi XDC's expertise in ADC development and manufacturing to produce high-quality GMP material for AKTX-101 [4][5]. Group 2: Product Development - AKTX-101 incorporates Akari's novel proprietary payload, PH1, which modulates RNA splicing and offers a differentiated approach to ADC design, potentially enhancing therapeutic impact [3][6]. - The manufacturing milestone is a significant step in advancing Akari's pipeline of differentiated ADC therapies, which aim to improve outcomes for cancer patients [5][6]. Group 3: Future Plans - The company plans to initiate a Phase 1 first-in-human clinical trial for AKTX-101 in approximately 12 months, pending regulatory clearance [4][5]. - Akari's innovative ADC design and payload technology, combined with WuXi's manufacturing capabilities, are expected to lay the groundwork for multiple ADC programs utilizing the PH1 payload [4][6].

Core Viewpoint - Akari Therapeutics has announced a definitive agreement for the issuance and sale of approximately 12.6 million American Depositary Shares (ADSs) and unregistered warrants, with significant participation from its Directors, Officers, and Executive Management, aimed at supporting its oncology drug development initiatives and improving its capital structure [1][4][6]. Group 1: Offering Details - The offering includes 10,043,774 ADSs in a registered direct offering priced at $0.3883 per ADS, along with unregistered Series G warrants [3]. - A concurrent private placement will issue unregistered pre-funded warrants for 2,563,713 ADSs at a combined price of $0.4041 per ADS [3]. - The gross proceeds from the offering are expected to be around $5 million, with over $1 million coming from new cash investments by the Company's Directors, Officers, and Executive Management [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for ongoing research and development, working capital, and general corporate purposes [4]. Group 3: Debt Conversion - Existing note holders have agreed to convert approximately $2.5 million of the Company's outstanding debt into unregistered pre-funded warrants and warrants to purchase 6,409,410 ADSs at a combined exchange price of $0.4041 per ADS [5]. Group 4: Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs), with its lead candidate AKTX-101 targeting the Trop2 receptor on cancer cells [10]. - The novel payload PH1 is designed to disrupt RNA splicing within cancer cells, showing significant activity and prolonged survival in preclinical studies compared to traditional ADCs [10].

Core Insights - Akari Therapeutics has announced promising preclinical data for its antibody-drug conjugate (ADC) AKTX-101, which targets Trop2 and shows potential in treating K-Ras G12V mutated pancreatic cancer, a highly lethal form of cancer with low survival rates [1][6] Industry Overview - Pancreatic cancer is one of the deadliest cancers, with approximately 60,000 new diagnoses and around 50,000 deaths annually in the U.S. The most common type, pancreatic ductal adenocarcinoma (PDAC), has limited treatment options, especially for K-Ras G12V mutation-driven tumors [2][3] Current Treatment Landscape - The standard treatments for K-Ras G12V-driven PDAC, such as FOLFIRINOX and gemcitabine plus nab-paclitaxel, yield poor outcomes with overall survival rates of 1.5 years and 1.3 years, respectively. There is a significant unmet need for targeted therapies in this area [3][4] AKTX-101 Mechanism and Efficacy - AKTX-101 is designed to deliver a novel RNA spliceosome modulating payload, PH1, to cancer cells expressing Trop2. This mechanism disrupts RNA splicing, which is crucial for cancer cell survival and proliferation. The ADC has shown significant cytotoxic potency in preclinical models, outperforming other investigational therapies [4][5] Future Development Plans - The company plans to present the preclinical data at a scientific conference and is advancing AKTX-101 towards a first-in-human trial expected to start in late 2026, with preliminary safety and efficacy data anticipated in 2027 [7]

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 - Akari Therapeutics is focused on developing novel payloads for antibody drug conjugates (ADCs), specifically highlighting its innovative PH1 payload and its dual mechanism of action [1][3] - The company aims to advance differentiated therapies for oncology patients through its next-generation ADC discovery platform [1][3] Company Overview - Akari Therapeutics is an oncology biotechnology company that specializes in next-generation spliceosome payload ADCs [3] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [3] Product Innovation - The PH1 payload is a spliceosome modulator designed to disrupt RNA splicing in cancer cells, which has shown potential to induce cancer cell death and activate immune responses [3] - Preclinical studies of AKTX-101, an ADC utilizing the PH1 payload, have demonstrated significant activity and prolonged survival compared to traditional ADCs [3] - AKTX-101 has shown potential synergy with checkpoint inhibitors, exhibiting prolonged survival both as a single agent and in combination with these inhibitors [3]