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]

Core Points - Akari Therapeutics is conducting a corporate update webcast to share important information with stakeholders [1] - The leadership team includes Abizer Gaslightwala as President and CEO, and Dr. Satyajit Mitra as Head of Oncology [4] Forward-Looking Statements - The webcast may contain forward-looking statements regarding management's intentions and expectations, which involve risks and uncertainties [2] - Actual results may differ materially from those projected in forward-looking statements due to various factors [3]

Core Insights - Akari Therapeutics has appointed Kameel D. Farag as Interim Chief Financial Officer, bringing over 20 years of experience in biopharma and global finance [1][2][4] - The company is focused on developing novel antibody drug conjugates (ADCs) that utilize a unique spliceosome modulator payload, aiming to disrupt cancer cell survival [2][7] Company Overview - Akari Therapeutics is an oncology biotechnology company specializing in next-generation spliceosome payload ADCs, with a platform capable of generating and optimizing ADC candidates for various targets [7] - The lead asset, AKTX-101, has shown significant preclinical activity and prolonged survival compared to traditional ADCs, with potential synergy with checkpoint inhibitors [7] Leadership Background - Kameel D. Farag previously served as CFO at Aspen Neuroscience, where he tripled the company's headcount and secured over $150 million in financing [4] - Farag has also held senior finance roles at Ionis Pharmaceuticals and Amgen, contributing to substantial revenue growth and operational improvements [4]

Financial Performance - The company reported a loss from operations of $7.4 million for the three months ended September 30, 2025, a 153% increase compared to a loss of $2.9 million for the same period in 2024[169]. - The company reported a 14% decrease in loss from operations for the nine months ended September 30, 2025, totaling $14.0 million compared to $16.4 million for the same period in 2024[169]. - The net loss applicable to common shareholders for the three months ended September 30, 2025, was $6.4 million, compared to a net loss of $2.9 million for the same period in 2024[201]. - As of September 30, 2025, the company had $2.5 million in cash and an accumulated deficit of $259.3 million, with no revenue generated to date[202]. - The Company reported a net change in cash of $(115,000) for the nine months ended September 30, 2025, compared to $(1,599,000) for the same period in 2024[228]. - As of September 30, 2025, the Company had net cash used in operating activities of $(7,527,000), an improvement from $(10,428,000) in the same period of 2024[228]. - The Company may face substantial doubt regarding its ability to continue as a going concern within one year due to recurring losses and the need for additional capital[226]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $7.4 million, which includes a $5.18 million non-cash impairment loss on other intangible assets[169]. - Research and development expenses for the three months ended September 30, 2025, were $249,000, an increase of $106,000 compared to $143,000 for the same period in 2024[172]. - HSCT-TMA clinical development expenses decreased by $0.5 million and $1.5 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024, due to the suspension of the AK901 clinical program[173]. - CMC expenses decreased by $0.4 million and $3.3 million for the three and nine months ended September 30, 2025, respectively, primarily due to the suspension of the pre-clinical PAS-nomacopan program[175]. - General and administrative costs increased by approximately $0.3 million and $0.5 million for the three and nine months ended September 30, 2025, respectively, mainly due to an increase in non-cash stock-based compensation[180][181]. Funding and Capital Structure - The company completed a registered direct offering on October 16, 2025, raising gross proceeds of $2.5 million by issuing 3,125,000 ADSs at a price of $0.80 each[164]. - The company entered into an Ordinary Share Purchase Agreement with White Lion Capital, allowing for the potential purchase of up to $25 million in newly issued Ordinary Shares[165]. - The Company entered into a placement agency agreement, paying $262,500 in cash for the 2025 Registered Direct Offering and granting warrants for 125,000 ADSs at an exercise price of $1.00 per ADS[208]. - Under the ELOC Purchase Agreement, the Company can require White Lion to purchase up to $25,000,000 in newly issued Ordinary Shares, subject to certain conditions[209]. - The Company has the right to control the timing and amount of sales of Ordinary Shares to White Lion, with a commitment period ending on August 29, 2028[210]. - The maximum number of Ordinary Shares that can be issued under the ELOC Purchase Agreement is capped at 13,039,369,358, representing 19.99% of the Company's outstanding shares[211]. - The Company issued August 2025 Notes with an aggregate purchase price of $3,011,000 and a principal amount of $3,763,750, with maturity dates ranging from August 15, 2026, to September 26, 2026[218]. - The Company has outstanding convertible notes and notes payable expected to result in principal payments of approximately $4.6 million as of September 30, 2025[231]. - The Company is seeking additional funding through equity and/or debt securities to continue operations, as it currently has no products approved for sale and does not generate revenue[222]. Management and Corporate Actions - The company has suspended internal development of legacy programs nomacopan and PAS-nomacopan to focus on the ADC platform[156]. - The company appointed Mr. Kameel Farag as Interim Chief Financial Officer, effective October 22, 2025, with a monthly cash fee of $18,000[162]. - The company recognized a gain on settlement of current liabilities of $0.8 million during the three months ended September 30, 2025[189]. - The company recognized an impairment loss related to in-process R&D of PHP 303 due to reprioritization of resources[182]. Research and Development - The company aims to establish AKTX-101 as a best-in-class Trop2-targeting ADC for treating various solid tumors[155]. - The company presented immune mechanism-of-action data for its novel ADC payload at the 2025 Society for Immunotherapy of Cancer Annual Meeting, indicating potential new treatment paradigms[161]. Accounting and Reporting - Management's discussion and analysis is based on unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP[234]. - No material changes to critical accounting policies and estimates have occurred since December 31, 2024[235]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[236].

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 Insights - Akari Therapeutics is presenting data on its novel antibody drug conjugate (ADC) payload, PH1, at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting, highlighting its immune mechanism-of-action and potential in oncology [1][2] Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload ADCs, with its lead candidate, AKTX-101, targeting the Trop2 receptor on cancer cells [5][6] - The PH1 payload is designed to disrupt RNA splicing within cancer cells, showing preclinical efficacy in inducing cancer cell death and activating immune cells [5][6] Research Findings - The abstract presented at SITC indicates that the PH1 ADC, in combination with anti-PD-1, resulted in a higher rate of complete tumor regressions compared to a first-in-class ADC with a microtubule inhibitor payload [2] - The immune response stimulated by the PH1 ADC is attributed to neoantigen activation, which enhances the activity of antigen-presenting cells, B, and T-cells [2] - Notably, the combination of PH1 ADC and anti-PD-1 expanded the population of gamma-delta T cells, which are effective in tumor killing [2] Presentation Details - The oral and poster presentations will take place on November 7 and 9, 2025, at the Gaylord National Resort and Convention Center, with specific times and locations provided for attendees [3][4]

Core Insights - Akari Therapeutics is presenting new data on its novel antibody drug conjugate (ADC) payload, PH1, at the 40th Annual SITC Meeting, highlighting its immune mechanism-of-action and potential in oncology treatment [1][2]. Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload ADCs, with its lead candidate, AKTX-101, targeting the Trop2 receptor on cancer cells [5]. - The PH1 payload is a spliceosome modulator designed to disrupt RNA splicing in cancer cells, showing preclinical efficacy in inducing cancer cell death and activating immune responses [5]. Research Findings - The abstract presented at SITC indicates that the PH1 ADC, in combination with anti-PD-1, resulted in a higher rate of complete tumor regressions compared to a first-in-class ADC with a microtubule inhibitor payload [2]. - The immune response stimulated by the PH1 ADC involves neoantigen activation, antigen-presenting cells, and T-cell activation, leading to enhanced therapeutic potential [2]. Presentation Details - The oral and poster presentations will provide further insights into the findings, with specific sessions scheduled for November 7 and November 9, 2025 [3][4].