Core Insights - Akari Therapeutics has filed two new provisional patent applications with the USPTO, focusing on its novel immuno-oncology payload PH1 and its combination therapy with other immuno-oncology drugs [1][2][3] Patent Applications - The first patent application protects Akari's novel immuno-oncology payload PH1, which is a Thailanstatin analog, and its mechanism of action that activates the host immune system against cancer [1] - The second application covers a combination therapy of PH1 ADCs with other immuno-oncology drugs that alleviate checkpoint inhibition, demonstrating synergy in preclinical models [1][3] Strategic Goals - The patent filings are part of Akari's strategy to establish a new class of immuno-oncology ADC therapies, building on the success of checkpoint inhibitors [2] - The company aims to enhance its intellectual property estate to create long-term value for itself and potential partners [2] Clinical Implications - Akari's data suggest the potential for a new ADC paradigm targeting cancer through spliceosome modulation, which could improve clinical outcomes compared to existing therapies [4] - Checkpoint inhibitors currently benefit only 20-30% of patients, indicating a significant opportunity for Akari's innovative approach [4] Pipeline Development - Akari is expanding its ADC pipeline to include multiple targets, such as AKTX-101 (Trop2 ADC with PH1 payload) and future programs like AKTX-102 [5][6] - The lead candidate AKTX-101 has shown significant activity and prolonged survival in preclinical studies, with potential synergy with checkpoint inhibitors [6]

Core Insights - Akari Therapeutics, Plc is an oncology biotechnology company focused on developing novel payload antibody drug conjugates (ADCs) [1][2] - The company’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and utilizes a proprietary linker to deliver a novel spliceosome modulator payload, PH1, designed to disrupt RNA splicing [2] - AKTX-101 has shown significant preclinical activity, inducing cancer cell death and activating immune cells, with potential synergy with checkpoint inhibitors [2] Presentation Details - Akari Therapeutics will present an abstract at the 40th Annual SITC Meeting, scheduled for November 5-9, 2025 [1] - The presentation titled "A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential beyond Cytotoxicity" will be delivered by Dr. Satyajit Mitra [1] - The oral presentation is set for November 9, 2025, at 11:05 AM ET, with a poster presentation on November 7, 2025 [1]

Core Insights - Akari Therapeutics has announced promising preclinical data for its novel antibody drug conjugate (ADC) payload, PH1, which targets the AR-V7 receptor linked to hormone refractory prostate cancer progression [1][2][3] Group 1: Product Development - PH1 has shown the ability to suppress AR-V7 receptor expression in a hormone-refractory metastatic castration resistant prostate cancer (mCRPC) model, indicating its potential effectiveness where current therapies fail [3] - In hormone-sensitive LnCAP cells, PH1 demonstrated single-agent benefits and additive effects when combined with existing therapies like Xtandi and Erleada, suggesting potential for first-line combination regimens [4] - The company aims to develop PH1 ADCs as either first-line therapies with ARPIs or second-line therapies for patients who have failed ARPI treatments [5] Group 2: Market Context - There is a significant unmet need for effective therapies in ARPI-resistant hormone refractory prostate cancer, as current options are limited primarily to traditional chemotherapy [2] - Current first-line therapies, including enzalutamide (Xtandi), apalutamide (Erleada), and darolutamide (Nubeqa), have substantial annual sales, indicating a lucrative market for effective alternatives [2] Group 3: Company Overview - Akari Therapeutics specializes in developing next-generation spliceosome payload ADCs, with its lead candidate, AKTX-101, targeting the Trop2 receptor and utilizing a novel PH1 payload [6] - The company’s innovative ADC discovery platform allows for the generation and optimization of ADC candidates tailored to specific targets, enhancing its competitive edge in oncology [6][7]

Core Insights - Akari Therapeutics has announced promising preclinical data for its novel antibody drug conjugate (ADC) payload, PH1, which targets the AR-V7 receptor linked to hormone refractory prostate cancer progression [1][2][3] Group 1: Product Development - The ADC payload PH1 has shown the ability to suppress AR-V7 receptor expression in a hormone-refractory metastatic castration resistant prostate cancer (mCRPC) model, indicating its potential effectiveness where current therapies fail [3][4] - In a hormone-sensitive model, PH1 demonstrated single-agent benefits and additive effects when combined with existing therapies like Xtandi and Erleada, suggesting potential for first-line combination regimens [4][5] - Akari aims to develop the first ADC therapeutic for prostate cancer, targeting both first-line and second-line treatment scenarios for AR-V7 driven tumors [5] Group 2: Market Context - There is a significant unmet need for effective therapies in ARPI-resistant hormone refractory prostate cancer, as current options are limited primarily to traditional chemotherapy [2][4] - Current first-line therapies, including enzalutamide, apalutamide, and darolutamide, have substantial annual sales, indicating a lucrative market for effective alternatives [2] Group 3: Company Overview - Akari Therapeutics specializes in developing next-generation spliceosome payload ADCs, with a focus on innovative therapeutic mechanisms that differ from traditional ADCs [6][7] - The lead candidate, AKTX-101, targets the Trop2 receptor and utilizes a proprietary linker to deliver the PH1 payload directly into tumors, aiming for enhanced efficacy and survival outcomes [6][7]

Industry Overview - Biotech and healthcare stocks are responding positively to clinical trial progress, regulatory developments, and economic indicators, particularly with the Federal Reserve's first rate cut of 2025, which is expected to improve funding conditions for capital-intensive sectors like biotechnology [1] Company Highlights - **Sonnet BioTherapeutics Holdings Inc. (SONN)**: Shares increased by 11.19% in after-hours trading, reaching $7.85 after a regular session close of $7.06. The stock has a 52-week range of $1.08 - $19.30. The company expanded clinical evaluation of its lead candidate, SON-1010, for ovarian cancer, reporting a strong safety profile and a partial response at the highest dose level [2][3] - **Akari Therapeutics Plc (AKTX)**: Shares surged 11.58% in after-hours trading to $0.8855 after closing at $0.7936. The stock has a 52-week range of $0.5710 - $3.8500. The increase follows a provisional patent filing for its antibody-drug conjugate platform aimed at cancer treatment, which is expected to enhance its intellectual property and support the development of first-in-class ADCs [4][5] - **Safety Shot Inc. (SHOT)**: Shares rose 9.75% in after-hours trading to $0.3333 after closing at $0.3037. The company announced a strategic refresh of its Board of Directors with three new members to strengthen its capabilities in digital assets and operations [6][7] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares climbed 10.09% in after-hours trading to $0.4451 after closing at $0.4043. The stock has a 52-week range of $0.3000 - $4.2800. The price movement follows a revised analyst rating maintaining a "Speculative Buy" while lowering the price target from $14.00 to $7.00. Reviva's lead candidate, brilaroxazine, is being developed for multiple neuropsychiatric and respiratory indications [8][9][10] - **Cognition Therapeutics Inc. (CGTX)**: Shares rose 7.48% in after-hours trading to $1.58 after closing down at $1.47. The company is focused on its lead candidate, Zervimesine, for Alzheimer's disease, and recently closed a $30 million offering to support its Phase 3 development [12][13]

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]

Company Overview - Akari Therapeutics is publicly listed on NASDAQ under the ticker AKTX [2] - The company is focusing on innovating antibody drug conjugates (ADCs) [3] Strategic Focus - Akari Therapeutics has redefined its vision to concentrate on oncology [3] - The company aims to develop immuno-oncology therapies to help patients achieve cancer-free status [4]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [4] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [4] Lead Product Candidate - Akari's 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 [4] - PH1 is a spliceosome modulator designed to disrupt RNA splicing within cancer cells, leading to cancer cell death and activation of immune cells [4] - Preclinical studies indicate that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs, and it shows potential synergy with checkpoint inhibitors [4] Upcoming Events - Abizer Gaslightwala, President and CEO of Akari Therapeutics, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1] - Management will also be available for in-person one-on-one meetings with qualified investors during the conference [2] - A video webcast of the presentation will be available on-demand starting September 5, 2025, and will be archived for 90 days [3]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [2][5] - The company has developed its first novel payload, PH1, which is a spliceosome modulator designed to disrupt RNA splicing within cells, differentiating it from current ADC payloads [5] Product Pipeline - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers the PH1 payload directly into tumors [5] - Preclinical studies have shown that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs [5] - The company is generating validating data on its novel payload PH1 to advance its lead asset and other undisclosed targets [5] Upcoming Events - Akari Therapeutics will participate in the Virtual Investor Closing Bell Series on September 4, 2025, where the CEO will provide a corporate overview and discuss the innovative payload platform [3][4] - Investors will have the opportunity to submit questions live during the event [3]

As filed with the Securities and Exchange Commission on August 29, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code) (I.R.S. Employer Identification No.) 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 22 Boston Wharf Ro ...