Akari Therapeutics, Plc is an oncology company focused on developing innovative antibody-drug conjugates for the treatment of solid tumors.

# Company Overview: Akari Therapeutics, Plc

**Business Model**  
Akari Therapeutics, Plc is an oncology company focused on developing next-generation antibody-drug conjugates (ADCs) designed around novel, proprietary cancer-killing toxins (payloads). The company's approach aims to transform the efficacy and safety profiles of ADCs relative to existing therapies.

**Products and Pipeline**  
1. **Lead Product Candidate: AKTX-101**
   - **Type:** ADC targeting Trop2
   - **Mechanism:** Utilizes PH1, a cytotoxic payload that disrupts spliceosome function, potentially inducing immune responses to cancer cells via neoepitope formation. 
   - **Development Stage:** Preclinical, with plans for Investigational New Drug (IND) application and initiation of clinical trials targeting solid tumors.

2. **Pipeline Candidates:**
   - **AKTX-102:** A discovery-stage bispecific ADC also utilizing the PH1 payload against a novel cancer target.
   - **PH5:** A novel payload targeting DNA mismatch repair (MMR) and DNA damage response (DDR).
   - **PH6:** A novel payload that inhibits DNA transcription in cancer and immune cells.

**Market Potential**  
The company aims to address cancers that are currently poorly served by existing therapies, with a focus primarily on solid tumors. As of the end of 2024, cancer remains a significant unmet medical need, with approximately 618,000 cancer-related deaths projected in the United States alone in 2025.

**Financial Overview**  
- **Employees:** 9 total (8 full-time), including key personnel with expertise in oncology.
- **Revenue:** As of December 31, 2024, the company has not commercialized any products and does not generate revenues yet.
- **Operating Losses:** Reported losses of $19.8 million and $10.0 million for the years ending December 31, 2024, and 2023, respectively.
- **Accumulated Deficit:** Approximately $247.3 million as of December 31, 2024.

**Business Strategy**  
Akari Therapeutics aims to leverage its proprietary ADC Platform to develop more effective cancer therapies, intending to advance multiple product candidates through rigorous preclinical and clinical development processes. Current efforts are heavily focused on the continued development of the ADC technology and exploring potential collaborations or out-licensing of legacy programs, which include earlier-stage compounds such as nomacopan. 

**Conclusion**  
With a concentrated focus on innovative ADCs and a small, specialized team, Akari Therapeutics is positioned in an evolving oncology landscape aimed at addressing significant unmet medical needs, despite operating at a loss and in the early stages of product commercialization. The company is actively working on developing its pipeline and maintaining financial viability through fundraising and strategic collaborations.

The company is a clinical-stage biotechnology firm focused on developing advanced therapies for autoimmune and inflammatory diseases, primarily through its product candidate nomacopan.


# Company Overview

## Business Focus
The company is a clinical-stage biotechnology firm dedicated to developing advanced therapies aimed at treating autoimmune and inflammatory diseases by targeting the complement component 5 (C5) and leukotriene B4 (LTB4) pathways. These pathways are believed to play significant roles in the pathogenesis of various diseases.

## Lead Product Candidate
- **Nomacopan**: 
  - A recombinant small protein (16,769 Da) derived from a protein found in the saliva of the Ornithodoros moubata tick.
  - Functions as a dual inhibitor of complement C5 and LTB4, preventing inflammation and prothrombotic activities.
  - Can be administered in various forms such as subcutaneous, intravenous, topical (e.g., for eye treatments), and intravitreal.

## Clinical Trials
- Currently conducting a clinical trial for subcutaneous nomacopan to treat hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) in pediatric patients.
- Planning potential registrational Phase 3 trials for both adult and pediatric HSCT-TMA.
- Exploring long-acting PASylated-nomacopan (PAS-nomacopan) for geographic atrophy (GA) secondary to dry age-related macular degeneration in preclinical studies.

## Designations and Approvals
- Nomacopan has received the following designations:
  - **Rare Pediatric Disease Designation** (from the FDA)
  - **Orphan Drug Designation** (in the U.S. and EU)
  - **Fast Track Designation** (for pediatric HSCT-TMA treatment)

## Pipeline Expansion
- Following an anticipated merger with Peak Bio Inc. scheduled for late Q2 2024, the company expects to broaden its pipeline, which includes a Phase 2-ready program targeting alpha-1 antitrypsin deficiency (PHP-303) and a novel pre-clinical antibody drug conjugate candidate.

## Financials
- **Employees**: As of March 15, 2024, the company had a total of **12 employees** (9 full-time).
- **Revenue**: The company has not yet commercialized any products, resulting in no significant revenue generation.
- **Losses**: The company incurred net losses of **$10.0 million** for the year ended December 31, 2023, and **$17.7 million** for 2022. The accumulated deficit as of December 31, 2023, was **$227.5 million**.

## Operations and Infrastructure
- The company primarily relies on third-party contract manufacturers for drug production adhering to Good Manufacturing Practices (GMP).
- The operations focus on research, development, and potentially commercialization of therapeutic candidates for unmet medical needs involving autoimmune and inflammatory conditions.

## Customers and Market
- The potential patient population for HSCT-TMA is estimated at **200-300 children** and **3,100-3,200 adults** in the U.S.
- For geographic atrophy, there are **over 5 million patients** worldwide, with approximately **1 million in the U.S.** alone.

## Conclusion
The company is focused on the development of innovative therapies, primarily nomacopan, with broad potential across multiple therapeutic areas. However, it faces challenges including funding, regulatory approvals, and establishing commercial partnerships.



Akari Therapeutics Plc

10-K / April 15, 2025

10-K / March 29, 2024

10-K / April 15, 2025

Company Overview: Akari Therapeutics, Plc