Core Insights - Akari Therapeutics is focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [2][4] - The company’s lead candidate, AKTX-101, utilizes a novel spliceosome modulator payload, PH1, which has shown significant preclinical activity [4] Company Overview - Akari Therapeutics is an oncology biotechnology company that has developed PH1, a spliceosome modulator designed to disrupt RNA splicing within cancer cells [4] - PH1 is differentiated from traditional ADC payloads that typically use Topoisomerase1 inhibitors or tubulin inhibitors, and it has demonstrated the ability to induce cancer cell death while activating immune cells [4] - AKTX-101 targets the Trop2 receptor on cancer cells, delivering the PH1 payload directly into tumors, and has shown prolonged survival in preclinical studies compared to traditional ADCs [4] Research and Development - The company is conducting ongoing research to further understand the effects of PH1 and its potential to disrupt key drivers of cancer cell growth [3][4] - Akari is generating validating data on PH1 to advance its lead asset and explore other undisclosed targets [4]

Core Insights - Akari Therapeutics is advancing its research on PH1, a novel spliceosome modulator that induces cancer cell death and activates the immune system to combat cancer [1][4] - The company is focused on developing antibody drug conjugates (ADCs) utilizing the PH1 payload, with ongoing preclinical studies expected to yield new data by year-end [1][3] Company Overview - Akari Therapeutics specializes in oncology biotechnology, developing innovative ADCs with a unique mechanism of action through the PH1 payload, which disrupts RNA splicing [4] - The lead candidate, AKTX-101, targets the Trop2 receptor and has shown significant activity and prolonged survival in preclinical studies compared to traditional ADCs [4] Research and Development - Ongoing research aims to explore the effects of PH1 on key oncogenic drivers such as KRAS, BRAF, and FGFR3, with preliminary data anticipated soon [2][3] - The PH1 payload has demonstrated the ability to induce cytotoxicity in cancer cells and activate immune responses, potentially leading to improved therapeutic outcomes [2][6]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [1][3] - The company has developed its first novel payload, PH1, which is a spliceosome inhibitor designed to disrupt RNA splicing within cells [3] - PH1 is differentiated from current ADC payloads that utilize Topoisomerase1 inhibitors or tubulin inhibitors, showing potential to induce cancer cell death while activating immune cells [3] Lead Candidate - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers the PH1 payload directly into tumors [3] - In preclinical studies, AKTX-101 has demonstrated significant activity and prolonged survival compared to traditional ADCs [3] - The candidate has potential synergistic effects with checkpoint inhibitors, showing prolonged survival both as a single agent and in combination with these inhibitors [3] Recent Developments - Abizer Gaslightwala, the CEO of Akari, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, discussing his dedication to the company and its programs [1][2] - The on-demand video webcast of the conference is available on virtualinvestorco.com and the company's website [2]

Akari Therapeutics Overview - Akari Therapeutics focuses on innovating antibody-drug conjugates (ADCs) as immuno-oncology therapies [3] - The company's lead payload, PH1, is a spliceosome inhibitor that causes cell death and activates the immune system [10] - Akari is developing novel target ADCs with the PH1 payload applicable to colon, lung, breast, and prostate cancers [12] PH1 Payload Mechanism and Advantages - PH1's mechanism of action generates mis-spliced transcripts leading to immunogenic neoantigens, 9 times greater than DM4 [23, 25] - PH1 overcomes resistance mechanisms and has reduced off-target toxicity due to its linker being engineered for intracellular release [17] - Preclinical data shows synergy between PH1 payload ADCs and checkpoint inhibitors [16] ADC Pipeline and Development - Akari's proprietary PH1 payload can build an entire ADC pipeline, with the ability to design several uniquely targeted ADCs in parallel [33] - AKTX-101 (Trop2 target) is ready for GMP manufacturing/GLP tox studies [36] - AKTX-102 is being developed against a novel target with potential in lung, colon, and breast cancers [36] Market Opportunity and Deal Flow - There is a strong need for ADCs with new payload mechanisms beyond current ADC therapies, especially in lung cancer [13] - Early-stage ADC deal flow shows continued momentum, with deals ranging from $20 million to $400 million upfront and total deal highlights reaching up to $1.34 billion [8] - One licensing deal for EO-1022 (HER3) reached $368 million in upfront and clinical, regulatory, and commercial milestone payments [8]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [2][4] - The company has developed its first novel payload, PH1, which is a spliceosome inhibitor designed to disrupt RNA splicing within cells, differentiating it from current ADC payloads [4] Recent Developments - Akari Therapeutics recently participated in a Virtual Investor segment where CEO Abizer Gaslightwala discussed the issuance of India Patent No. 562,919 for "Thailanstatin Analogs," which covers claims for its PH1 payload and ADC technology [3] - The PH1 payload has shown significant activity in preclinical studies, inducing cancer cell death and activating immune cells, leading to robust and durable activity [4] Product Pipeline - The lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and utilizes a proprietary linker to deliver the PH1 payload directly into tumors [4] - AKTX-101 has demonstrated significant activity and prolonged survival in preclinical studies compared to traditional ADCs, and it has potential synergistic effects with checkpoint inhibitors [4]

Core Viewpoint - Akari Therapeutics has announced the issuance of a new patent in India for its innovative immuno-oncology payload, PH1, which is designed to inhibit RNA splicing and enhance cancer treatment options as cancer rates rise in the region [1][3]. Company Overview - Akari Therapeutics is focused on developing novel antibody drug conjugates (ADCs) for cancer treatment, with its lead candidate, AKTX-101, targeting the Trop2 receptor on cancer cells [6]. - The company has developed PH1, a spliceosome inhibitor that disrupts RNA splicing, leading to cancer cell death and immune system activation [6]. Patent Details - The newly issued Patent No. 562,919 covers the company's PH1 payload, proprietary linkers, and ADC technology applicable to various cancer targets [2][4]. - This patent strengthens Akari's global intellectual property portfolio and provides additional protection for its manufacturing activities related to PH1 [3]. Market Context - India is identified as a key market for Akari, with cancer cases projected to rise to 2.08 million by 2040, highlighting the increasing need for innovative cancer therapies [1][3]. - The issuance of the patent is seen as a strategic move to capitalize on the growing demand for cancer treatments in India [3]. Research and Development - Akari is advancing a pipeline of potentially first-in-class ADC candidates that have demonstrated significant tumor-killing activity in preclinical models [5]. - The company aims to leverage its innovative payload platform to create multiple ADC molecules targeting a range of cancer types [5].

Summary of Akari Therapeutics Conference Call (May 29, 2025) Company Overview - **Company**: Akari Therapeutics (AKTX) - **Focus**: Development of antibody drug conjugates (ADCs) with novel immuno-oncology payloads aimed at improving cancer treatment outcomes [2][5] Key Points and Arguments Novel Approach to ADCs - Akari is innovating ADCs by using immuno-oncology payloads that differ from traditional cytotoxic agents, aiming to enhance efficacy and safety in cancer treatment [3][5] - The lead asset, AKTX-101, targets TROP-2, a marker on cancer cells, and is conjugated with a novel payload called pH-1 [9][10] Mechanism of Action - The pH-1 payload targets the spliceosome, leading to cancer cell death and priming the immune system to attack similar cancer cells [8][27] - This approach aims to create immunological memory, allowing the immune system to recognize and attack cancer cells upon re-exposure [34] Clinical Development and Safety - Preclinical data shows robust activity for AKTX-101 as a single agent and in combination with checkpoint inhibitors, with favorable safety profiles observed in nonhuman primate studies [10][12] - Akari is advancing its lead ADC into IND-enabling studies to prepare for Phase 1 trials [20] Market Potential and Competitive Landscape - The ADC market is experiencing significant interest, with major pharmaceutical companies investing heavily in this space, indicating a strong opportunity for Akari's differentiated approach [22][23] - Akari's unique payload distinguishes it from competitors, which primarily use microtubule inhibitors or topo-I inhibitors [24][27] Future Directions - Akari plans to explore additional targets for its pH-1 payload, including colon, lung, and prostate cancers, which represent significant unmet medical needs [12][20] - The company is open to partnerships for further development and commercialization of its ADC platform [21][36] Additional Important Content - The transition from an inflammation-focused portfolio to oncology was driven by the potential of the pH-1 platform and the strategic direction of the company [39] - Akari's leadership team includes experienced professionals from major pharmaceutical companies, enhancing its capability to execute its vision [14][15][18] Conclusion - Akari Therapeutics is positioned to leverage its innovative ADC platform to address significant challenges in cancer treatment, with a focus on enhancing patient outcomes through novel immuno-oncology strategies [36][37]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [3] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [3] Product Development - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and uses a proprietary linker to deliver a novel PH1 payload directly into tumors [3] - PH1 is a spliceosome inhibitor designed to disrupt RNA splicing within cancer cells, leading to cancer cell death and activation of immune cells [3] - Preclinical studies indicate that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs, and it shows potential synergy with checkpoint inhibitors [3] Leadership Announcement - The company announced the appointment of Mark F. Kubik as the Head of Business Development – Oncology, along with the release of a "Meet the Team" video [2]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [3] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [3] Lead Product Candidate - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers a novel PH1 payload directly into tumors [3] - PH1 is a spliceosome inhibitor designed to disrupt RNA splicing within cancer cells, leading to cancer cell death and activation of immune cells [3] - Preclinical studies indicate that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs [3] Synergistic Potential - AKTX-101 has shown potential for synergy with checkpoint inhibitors, demonstrating prolonged survival both as a single agent and in combination with these inhibitors [3] Upcoming Presentation - Abizer Gaslightwala, President and CEO of Akari, will present recent corporate events at the Virtual Biotech Investment Webinar on May 29, 2025 [1][2]

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].