Akari Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Operating expenses were $4.7 million for the three months ended September 30, 2026, compared to $7.4 million in the same period in 2025.
• Research and development expenses were approximately $2.1 million for the quarter ended September 30, 2026, compared to approximately $0.2 million in the comparable 2025 period.
• General and administrative expenses were approximately $2.6 million for the quarter ended September 30, 2026, compared to approximately $2.0 million in the comparable 2025 period.
• Loss from operations was approximately $4.7 million for the quarter ended September 30, 2026, compared to approximately $7.4 million in the comparable 2025 period.
• Net loss was approximately $4.8 million for the quarter ended September 30, 2026, compared to approximately $6.4 million in the comparable 2025 period.
• Net cash used in operating activities was approximately $9.8 million for the nine months ended September 30, 2026.
• Cash balance totaled approximately $5.7 million as of September 30, 2026, compared to approximately $5.2 million as of December 31, 2025.
• The Company received approximately $2.9 million in proceeds from the exercise of outstanding warrants during the third quarter of 2026.
• The Company repaid in full $0.7 million of outstanding convertible notes at their August 31, 2026 maturity, leaving no convertible notes or notes payable outstanding as of September 30, 2026.
• The prior-year quarter loss from operations included a $5.2 million impairment charge related to the former PHP-303 program.

Guidance and Future Outlook:

• The Company plans to initiate a First-In-Human Phase 1 clinical trial for lead candidate AKTX-101 in mid-2027, subject to obtaining additional financing.
• IND-enabling activities, including non-clinical and CMC/manufacturing work, are ongoing to support the Phase 1 filing by mid-2027.
• Management aims to expand the PH1 payload platform's application through internal development and external strategic partnerships.

Business Segments and Product Lines:

• GLP toxicology studies for lead candidate AKTX-101, a TROP2-targeted ADC utilizing the proprietary PH1 payload, have been initiated.
• Preclinical findings demonstrated statistically significant tumor growth inhibition in the UM-UC-14 advanced urothelial carcinoma model, where Padcev® showed limited activity.
• AKTX-101 showed encouraging activity in a tumor model of acquired resistance to Trodelvy® (sacituzumab govitecan), with tumor growth slowing after switching to AKTX-101.
• Early discovery work continues for AKTX-102, a CEACAM5-targeted ADC candidate utilizing the PH1 payload.
• A collaboration with Whitehawk Therapeutics was announced to explore the development of a novel dual payload construct for an ADC utilizing the PH1 payload.
• The Company filed international patent application PCT/US2026/45955 covering PH1's modulation of alternative RNA splicing pathways.

Market and Competitive Landscape:

• The ADC landscape is evolving, with management believing the next wave of innovation will be driven by novel payloads capable of overcoming limitations of current treatments.
• AKTX-101 targets patients refractory to current ADCs utilizing topoisomerase or microtubule inhibitor payloads.
• The PH1 payload is designed to disrupt RNA splicing, a mechanism distinct from current ADCs that use microtubule inhibitors and DNA-damaging agents.
• Preclinical data suggests the PH1 payload is active against cancer cells with key oncogenic drivers such as KRAS, BRAF, AR-V7, and FGFR3 fusions.

Risks and Challenges:

• The planned Phase 1 clinical trial is subject to obtaining additional financing.
• The Company faces risks related to the need for additional capital, potential delays in research and development, and regulatory approval uncertainties.
• Risks include potential loss of patents or intellectual property rights, supply chain interruptions, and competition for product candidates.
• Actual results may differ materially from forward-looking statements regarding the timing of IND filing and Phase 1 trial commencement.

Management Commentary and Tone:

• Abizer Gaslightwala, President and CEO, stated the Company is entering an important phase translating the PH1 payload platform into a defined path toward clinical development.
• Management believes the PH1 payload offers a competitive advantage for treating patients relapsing on current ADC therapies and could become a first-line ADC of choice.
• Satyajit Mitra, Executive Director, Head of Oncology, noted that findings support further evaluation of AKTX-101 after progression on prior ADC therapy and reinforce the hypothesis that a different payload mechanism may address payload-specific resistance.

Other Key Points:

• In October 2026, the Company appointed Vatnak Vat-Ho as Chief Business Officer, bringing over 20 years of experience and involvement in transactions totaling more than $25 billion.
• The Company's cash balance of $5.7 million represents the second highest balance since 2024.
• The increase in G&A expenses was primarily attributable to higher professional fees and a one-time cost associated with the termination of an agreement with a prior placement agent.
• The PH1 payload has demonstrated the potential to be synergistic with checkpoint inhibitors in preclinical studies.