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]

Well-established industry leader whose oncology expertise and transactions record has led to multiple approved therapeutic products and advanced clinical product candidatesAccess the video here BOSTON and LONDON, May 29, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced the release of a “Meet the Team” video featuring newly appointed Mark F. Kubik, Head of Business Development – Oncolog ...

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].

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]

Core Insights - Akari Therapeutics has appointed Mark F. Kubik as Head of Business Development - Oncology, leveraging his extensive experience in oncology therapeutics and transformative deal-making [1][2][3] Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [6] - The lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and utilizes a proprietary linker to deliver a novel PH1 payload directly into tumors [6][7] Leadership and Expertise - Mark F. Kubik brings over 25 years of experience in the oncology sector, having held leadership roles at various companies including I-MAB Biopharma, Genor Biopharma, and Actinium Pharmaceuticals [2][4] - His previous achievements include leading a transaction that resulted in OncoImmune being sold to Merck for $425 million upfront [4] Product Development - AKTX-101 is positioned as a first-in-class immuno-oncology ADC therapy, with preclinical studies indicating significant activity and prolonged survival compared to traditional ADCs [7] - The novel PH1 payload is designed to disrupt RNA splicing within cancer cells, potentially enhancing therapeutic efficacy and synergy with checkpoint inhibitors [7] Market Positioning - There is increasing interest from Big Pharma in early-stage ADCs, highlighting the potential for Akari to capitalize on this trend with its innovative ADC platform [4]

Core Insights - Akari Therapeutics is focused on developing next-generation precision bi-functional antibody drug conjugates (ADCs) for cancer treatment [2][3] - The company has appointed Abizer Gaslightwala as the new President and CEO, who shares his vision for the company's future [2] Company Overview - Akari Therapeutics utilizes an innovative ADC discovery platform to create novel bi-functional ADC candidates aimed at targeting various cancers [3] - The 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 [3] - PH1 is designed to disrupt RNA splicing within cancer cells, inducing tumor-specific cell death while minimizing off-target toxicity [3] - Preclinical studies indicate that AKTX-101 has superior activity, prolonged survival, less resistance, and better tolerability compared to current ADCs [3] - The candidate has shown potential for synergy with checkpoint inhibitors and has demonstrated prolonged survival in preclinical models [3] Future Directions - The company is generating validating data on its novel payloads to advance its pipeline [3]

Core Insights - Akari Therapeutics is advancing the development of next-generation precision bi-functional antibody drug conjugates (ADCs) to treat various cancer types, with a focus on its lead program, AKTX-101, for solid tumors [1][2][10] - The company has made strategic leadership appointments to enhance its capabilities and is well-positioned to capitalize on opportunities in the ADC space [2][3] - Akari's innovative platform technology allows for the generation of novel ADC candidates that aim to overcome limitations of existing therapies [3][5][10] Program Highlights - Following the merger with Peak Bio, Akari is concentrating on discovering and developing novel anti-cancer payloads with unique mechanisms of action [3] - The company is advancing a pipeline of potentially first-in-class ADC candidates designed to target and kill cancer cells while stimulating the immune system [3][5] Lead Candidate: AKTX-101 - AKTX-101 is a novel TROP2 PH1 ADC that utilizes a spliceosome inhibitor with multiple anti-tumor mechanisms [4][10] - Preclinical studies indicate that AKTX-101 has superior activity, prolonged survival, reduced resistance, and better tolerability compared to current ADCs [5][10] Financial Overview - For the fiscal year ended December 31, 2024, Akari reported a net loss from operations of approximately $21.6 million, an increase from $16.8 million in 2023, primarily due to merger-related costs and increased R&D expenses [7][8][19] - Research and development expenses were approximately $7.0 million for 2024, up from $5.5 million in 2023, while general and administrative expenses decreased to approximately $9.7 million from $11.4 million [8][19] - As of December 31, 2024, the company had cash of approximately $2.6 million, which, along with net proceeds from a private placement, is expected to fund operations into September 2025 [9][10] Legacy Pipeline Assets - The company is actively seeking development partners to secure non-dilutive capital for its legacy pipeline assets [6][10] Executive Team and Strategic Direction - Akari has made key leadership appointments to strengthen its executive team, including the appointment of Abizer Gaslightwala as President and CEO effective April 21, 2025 [2][13]

Product Development and Pipeline - The company is developing next-generation antibody-drug conjugates (ADCs) with novel payloads aimed at improving efficacy and safety in cancer therapies[19]. - The lead product candidate, AKTX-101, targets Trop2 and is in preclinical stage, focusing on solid tumors such as lung, breast, colon, and prostate cancers[26]. - The ADC platform includes additional candidates like AKTX-102, which targets a novel cancer antigen and is in discovery stage[27]. - The company aims to advance AKTX-101 to IND and initiate first-in-human trials, with a focus on maximizing commercial opportunities[29]. - The company is evaluating the first generation of PH5 linker-toxins against an undisclosed MMR/DDR target, which may enable bystander killing of neighboring cells[52]. - AKTX-101, the lead ADC product candidate, targets Trop2, which is upregulated in various malignant tumors, and has shown greater cytotoxicity at lower drug doses compared to a currently approved Trop2-targeting ADC[57][59]. - In preclinical studies, 50% of mice treated with AKTX-101 experienced tumor regression, compared to 20% for the currently approved Trop2 ADC[59]. - The proprietary L22 linker in AKTX-101 may provide a superior safety profile, demonstrating minimal killing of normal human fibroblasts compared to other Trop2-targeting ADCs[62]. - AKTX-101 was well-tolerated in a non-human primate model, with observed side effects resolving within weeks and no evidence of severe complications associated with other Trop2-targeting ADCs[63]. - The company has not initiated clinical studies for any of its active pipeline programs, which may delay commercialization for years[191]. - The company has not yet commenced or completed any clinical trials for its product candidates, indicating a high risk of failure in development[202]. Financial Performance and Capital Requirements - The company incurred net losses of $19.8 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $247.3 million as of December 31, 2024[178]. - The company has not commercialized any products or generated revenue from product sales, and expects to incur significant losses for the foreseeable future due to ongoing research and development activities[179]. - As of December 31, 2024, the company had cash of approximately $2.6 million and will require substantial additional capital to fund operations and product development[181]. - The company has cumulative net operating loss carryforwards of approximately $145.7 million in the UK, $38.1 million in the U.S. federal, and $71.8 million in various U.S. states, among others[187]. - The company may not have the financial resources to continue development of its product candidates if regulatory approvals are delayed or not obtained[194]. - The inability to complete development or significant delays in commercialization could materially adversely affect the company's business and financial condition[195]. - The development of pharmaceutical products is lengthy and expensive, with uncertain timelines and outcomes, which may delay commercialization[196]. Regulatory Environment and Compliance - The FDA regulates the drug approval process, requiring substantial time and financial resources for compliance[89]. - The NDA or BLA submission process involves a thorough review by the FDA, which may include additional information requests[98]. - The FDA may impose conditions on approval, such as a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the product[99]. - The FDA's review process assesses the safety, efficacy, and manufacturing compliance of the product before approval[100]. - The FDA may issue a complete response letter (CRL) requiring additional data for NDA or BLA approval[101]. - Standard review for an NDA takes ten months, while priority review can expedite this to six months for significant improvements in treatment[102]. - The Pediatric Research Equity Act mandates pediatric studies for most new drugs unless a deferral or waiver is granted[104]. - The Best Pharmaceuticals for Children Act provides a six-month exclusivity period for NDA holders if pediatric studies are completed[106]. - The Biologics Price Competition and Innovation Act grants a twelve-year exclusivity period for the first approved biological product[108]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained post-approval[120]. - The CT Regulation aims to streamline clinical trial approvals in the EU through a single-entry point and a centralized EU portal called the Clinical Trials Information System (CTIS)[125]. - The centralized authorization procedure allows for a single application to obtain marketing authorization valid in all EU Member States, mandatory for certain medicinal products[127]. - Conditional marketing authorizations can be granted prior to comprehensive clinical data if the product fulfills unmet medical needs and the risk-benefit balance is positive[132]. - The marketing authorization is valid for five years and can be renewed based on a re-evaluation of the risk-benefit balance[138]. - The Pediatric Investigation Plan (PIP) must be complied with before obtaining marketing authorization, covering all subsets of the pediatric population[135]. - The European Commission introduced legislative proposals in April 2023 to reform the regulatory framework for all medicines in the EU[151]. - Non-compliance with EU pharmacovigilance requirements can lead to significant financial penalties[144]. - The EMA's Committee for Medicinal Products for Human Use (CHMP) has 210 days to adopt an opinion on marketing authorization applications, which can be reduced to 150 days for accelerated assessments[129]. Strategic Focus and Partnerships - The company has suspended development of legacy programs nomacopan and PAS-nomacopan to focus on ADCs following the merger with Peak Bio, completed in November 2024[27]. - The strategy includes leveraging novel payloads and antibody-payload linkers for partnerships with biopharmaceutical companies[34]. - The company plans to out-license legacy non-oncology assets to raise capital for advancing ADC product candidates[34]. - The company may pursue opportunities to acquire or in-license additional businesses, technologies, or products[220]. - Strategic alliances or joint ventures may be formed to complement or augment the existing business[220]. Risks and Challenges - The biotechnology and pharmaceutical industries are characterized by rapid technological evolution and strong competition, impacting the company's ability to differentiate its products[71][73]. - The company faces risks if it cannot maintain and enforce its patent rights, which could allow competitors to develop similar technologies[84]. - There is no assurance that the company's patent applications will result in additional patents or that existing patents will provide sufficient protection against competitors[85]. - The company has issued composition-of-matter patents for nomacopan, but the validity of these patents could be challenged[86]. - Regulatory approvals are subject to significant variability, and the commercial success of approved products relies heavily on third-party payor coverage and reimbursement[197]. - The proprietary ADC Platform is based on unproven technologies, which may not lead to marketable products, exposing the company to unforeseen risks[217]. - Preclinical studies for the lead program AKTX-101 have only recently begun, with no clinical data generated yet, raising concerns about feasibility[218]. - Patient enrollment in clinical trials is influenced by various factors, including trial design and competing therapies, which may complicate timely completion[206]. - The company faces challenges in demonstrating safety and efficacy, which could result in additional costs and impair revenue generation from future product sales[210]. - The FDA's lack of experience in evaluating the company's product candidates may lead to longer regulatory review processes and increased development costs[219].