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]

Core Insights - Akari Therapeutics is focused on developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads to treat various cancer tumors [1][2] - The company appointed Mark Kubik as the new Head of Business Development for Oncology, enhancing its executive team with deep oncology experience [2] - Akari's lead asset, AKTX-101, targets the Trop2 receptor and utilizes the innovative PH1 payload, which is a spliceosome inhibitor designed to induce cancer cell death while activating immune responses [8] Financial Performance - For Q1 2025, Akari reported a net loss of approximately $3.7 million, a decrease from $5.6 million in Q1 2024 [4][16] - Research and development expenses were $0.8 million in Q1 2025, down from $2.3 million in the same period of 2024, primarily due to the suspension of the HSCT-TMA clinical program [4] - General and administrative expenses decreased to approximately $2.7 million in Q1 2025 from $3.7 million in Q1 2024, attributed to reduced legal and professional fees [5] Pipeline and Development Milestones - The company is advancing a pipeline of potentially first-in-class ADC candidates, with significant tumor-killing activity observed in preclinical models [2] - Upcoming milestones include presenting preclinical data on the PH1 payload's immuno-oncology activity at a scientific conference in the second half of 2025 [6] - Akari is exploring preclinical activity for AKTX-101 in various solid tumor indications and seeking strategic partners for research collaborations [6] Cash Position and Funding - As of March 31, 2025, Akari had cash of approximately $2.6 million, with net proceeds from a March 2025 offering totaling around $6.0 million [7] - The company continues efforts to out-license non-core assets in inflammation, ophthalmology, and rare diseases to generate non-dilutive capital for its ADC platform [3]

Financial Performance - Loss from operations for Q1 2025 totaled $3.5 million, a 41% decrease from $6.0 million in Q1 2024[140] - Total operating expenses for Q1 2025 were $3.525 million, down 41% from $5.989 million in Q1 2024[140] - Net loss applicable to common shareholders for the three months ended March 31, 2025, was $3.7 million, an improvement from a net loss of $5.6 million in the same period of 2024[159] - The company has substantial doubt regarding its ability to continue as a going concern within one year after the issuance of its financial statements due to recurring losses and the need for additional capital[178] Research and Development - Research and development expenses decreased by approximately $1.5 million, or 64%, from $2.279 million in Q1 2024 to $813,000 in Q1 2025[142] - HSCT-TMA clinical development expenses dropped by $571,000, or 90%, from $633,000 in Q1 2024 to $62,000 in Q1 2025 due to program suspension[143] - ADC preclinical development expenses increased by $17,000, marking a 100% increase from $0 in Q1 2024[142] - Future research and development expenditures will depend on future funding availability[149] - The company has not commercialized any products and expects substantial operating losses to continue for the foreseeable future due to ongoing research and development efforts[161] Funding and Capital - The March 2025 private placement raised approximately $6.0 million in net proceeds, with $4.0 million received in April 2025[133] - The company entered into a private placement in November 2024, raising approximately $3.2 million through the sale of 1,713,402 ADSs at a price of $2.26 per ADS[165] - In May 2024, the company raised approximately $7.0 million from a private placement involving 4,029,754 ADSs at a price of $1.885 per ADS[167] - The company is currently seeking additional funding through equity and/or debt securities to support its operations and obligations[172] Cash Flow and Expenses - For the three months ended March 31, 2025, net cash used in operating activities was $(2,150) thousand, a decrease from $(4,044) thousand for the same period in 2024[180] - Net cash provided by financing activities for the three months ended March 31, 2025, was $2,133 thousand, compared to $1,514 thousand in 2024[180] - The net change in cash for the three months ended March 31, 2025, was $(17) thousand, compared to $(2,535) thousand in 2024[180] - The decrease in cash used in operating activities was primarily due to deferrals of payables to preserve cash until additional capital is raised[180] Workforce and Restructuring - A reduction-in-force of approximately 67% of the workforce was implemented in May 2024 as part of an operational restructuring plan[136] Other Financial Information - As of March 31, 2025, the company had $2.6 million in cash and an accumulated deficit of $251.0 million, with no revenue generated to date[160] - The company recorded a non-cash revaluation loss of less than $0.1 million on warrant liabilities for the three months ended March 31, 2025, compared to a gain of $0.6 million in the same period of 2024[156] - The company incurred a total of $204,000 in placement agent fees related to the November 2024 private placement, with net proceeds of approximately $2.8 million after expenses[166] - As of March 31, 2025, principal payments expected from debt obligations assumed during the Merger amount to approximately $1.6 million[183] - The company entered into a short-term financing arrangement in January 2025, financing insurance premiums totaling $0.5 million[182] - There were no investing activities reported for the three months ended March 31, 2025 and 2024[181] - The company has not reported any material changes to its critical accounting policies and estimates since December 31, 2024[187] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[188]