Akari Therapeutics Q2 2024 Financial Results and Highlights

Akari Therapeutics, Plc, a biotechnology company focused on autoimmune and inflammatory disease treatments, recently announced its financial results for the second quarter ending June 30, 2024, along with key company updates. The company, listed on Nasdaq under the symbol AKTX, is making strides in several areas, particularly in the development of its PAS-nomacopan therapeutic for geographic atrophy (GA).

Dr. Samir R. Patel, who took over as Interim CEO four months ago, shared that Akari has made significant progress with its PAS-nomacopan program. In July, the company received encouraging feedback from the US FDA on its pre-Investigational New Drug (Pre-IND) application, and it plans to file a full IND application in 2025 for Phase 1 clinical trials. Akari has also successfully produced its first full-scale batch of PAS-nomacopan under Good Manufacturing Practice (GMP) conditions, suitable for clinical use, with assistance from Wacker Biotech GmbH. This batch will support both final IND-enabling studies and initial clinical trials.

Aside from the progress on PAS-nomacopan, Akari is also working on completing its merger with Peak Bio, which is expected to close in the fourth quarter of 2024. The merged entity will prioritize Peak’s antibody drug conjugate (ADC) technology and Akari’s PAS-nomacopan program. This strategic pivot led to the suspension of Akari’s HSCT-TMA program.

Recent organizational changes include the appointment of Dr. Patel as Interim CEO, compensated solely through equity. The company also implemented cost-reduction measures, including a reduction in the workforce and the elimination of certain senior management roles. Dr. Patel and Dr. Ray Prudo, the Chairman of the Board, each provided $500,000 in unsecured convertible notes to support the company’s operations. Moreover, Akari raised $7.6 million through a private placement involving American Depositary Shares (ADSs) and warrants.

Financially, Akari's cash reserves increased to $4.2 million as of June 30, 2024, up from $3.8 million at the end of 2023. Research and development expenses rose significantly to $3.3 million for the quarter and $5.6 million year-to-date, largely due to increased costs associated with PAS-nomacopan’s development. General and administrative expenses decreased to $2.2 million for the quarter and $4.9 million year-to-date, attributed to the reduced headcount following the workforce reduction. The company also incurred merger-related costs of $0.3 million for the quarter and $1.3 million year-to-date due to the Peak Bio merger. Net loss for the quarter stood at $7.6 million and $13.1 million for the first half of the year.

The merger between Akari and Peak Bio, announced in March 2024, will create a combined entity continuing under the Akari Therapeutics name and trading on the Nasdaq Capital Market. The merger terms include an all-stock transaction with an implied equal equity ownership split between Akari and Peak shareholders, contingent on certain adjustments. This merger aims to leverage the strengths of both companies, with Akari’s PAS-nomacopan program and Peak’s ADC technology at the forefront.

In summary, Akari Therapeutics is advancing its therapeutic platforms while strategically restructuring through a merger with Peak Bio. The company is focused on its PAS-nomacopan development for GA and exploring additional licensing and partnership opportunities. Financially, Akari is managing increased research costs while streamlining its operations to support long-term strategic goals. The merger with Peak Bio is a significant step, promising to enhance the combined entity's capabilities and market presence.