On April 16, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing next-generation precision bi-functional antibody drug conjugates (ADC) for the treatment of cancer, reported its financial results for the fiscal year ended December 31, 2024 and provided a corporate update (Press release, Akari Therapeutics, APR 16, 2025, View Source [SID1234651955]).

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"2024 was a transformational year for Akari with the successful completion of our merger with Peak Bio Inc., and renewed focus on advancing our next-generation precision ADC pipeline candidates," commented Samir R. Patel, M.D., President and Chief Executive Officer of Akari Therapeutics. "Looking ahead, we have made strategic leadership appointments with key skillsets to continue setting the Company up for success. We recently announced the appointment of Abizer Gaslightwala, a seasoned oncology executive with an impressive track record, who will serve as Akari’s President and Chief Executive Officer, effective April 21, 2025. I believe with our innovative platform technology and preclinical data demonstrated to date, Akari is well-positioned to become a key player in the ADC space and capitalize on the significant deal-flow seen in early ADC development. We look forward to an exciting year ahead and remain focused on the successful execution of our capital-efficient development strategies."

Program Highlights

Following the completed merger with Peak Bio, Inc. in November 2024, Akari has focused its efforts on the discovery, research and development of novel anti-cancer payloads with mechanisms of action that differ from currently approved ADC therapies and the application of those payloads against clinically validated targets. Leveraging its platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates that are designed to target and kill cancer cells and stimulate the immune system, or bifunctional ADCs, all while potentially overcoming the limitations inherent in existing therapies.

Lead Candidate: AKTX-101 (TROP2 PH1 ADC) – Novel Payload is a Spliceosome Inhibitor With Multiple Anti-Tumor Mechanisms

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Potential to overcome shortcomings of current ADCs
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Immunostimulatory effects
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Reduced off-target toxicity
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Overcomes resistance mechanisms
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Potential for synergy with immunotherapies

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Significant advantages over current TROP2 ADCs observed in multiple preclinical models:
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Superior activity
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Prolonged survival
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Less resistance
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Better tolerability
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Prolonged survival in combination with checkpoint inhibitors (CPI)

Upcoming Expected Value-Driving Milestones

Next-Generation Precision Bi-Functional ADC Platform

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Present anticipated PH1 Payload preclinical data at scientific conference
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Complete additional preclinical studies for AKTX-101

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Continue to advance pipeline by generating additional validating data on PH1 payload while advancing discovery work on additional novel payloads PH5 and PH6
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Round out Executive Team with critical hires
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Seek licensing/strategic partner for AKTX-101 (TROP2 PH1 ADC)

Legacy Pipeline Assets

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Continue Business Development efforts to secure development partners and provide non-dilutive capital

Summary of Financial Results for Full Year 2024

The net loss from operations for the year ended December 31, 2024 was approximately $21.6 million compared to approximately $16.8 million for the comparable period in 2023. The increase in net loss from operations is primarily attributable to merger related costs of $3.3 million, restructuring costs of $1.7 million and an increase in research and development expenses of $1.5 million which was offset by a reduction in general and administrative expenses of $1.7 million.

The Company reported research and development expenses of $7.0 million for the year ended December 31, 2024 compared to approximately $5.5 million for the comparable period in 2023.

General and administrative expenses were approximately $9.7 million for the year ended December 31, 2024 compared to approximately $11.4 million for the year ended December 31, 2023.

As of December 31, 2024, the Company had cash of approximately $2.6 million. Management anticipates that its cash on hand as of December 31, 2024 including the net proceeds from the private placement of $6.6 million announced in March 2025, is sufficient to fund operations into September 2025.