On November 12, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX) ("Akari" or the "Company"), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing disrupting payload, reported financial results for the third quarter ended September 30, 2026, and highlighted significant progress advancing its proprietary PH1 payload platform toward Phase 1 clinical development.

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Akari continues to execute against its strategic priorities, achieving important milestones to advance its novel ADC payload toward clinical validation. With GLP toxicology studies initiated for its lead candidate AKTX-101, and new preclinical findings demonstrating activity in models resistant to existing ADC therapies, the Company is advancing toward its planned first-in-human Phase 1 clinical trial in mid-2027, subject to obtaining additional financing. In parallel, the Company continues to pursue strategic opportunities to develop the PH1 payload in unique ways, including a dual ADC payload concept, as announced through the Whitehawk Therapeutics research collaboration.

"We are entering an increasingly important phase in Akari’s evolution, as we translate the differentiated potential of our PH1 payload platform into a defined path toward clinical development," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "The initiation of GLP toxicology studies represents a critical step toward bringing AKTX-101 into the clinic. Our latest preclinical findings provide further evidence of what we believe could be a meaningful competitive advantage of our unique ADC payload that disrupts RNA splicing: initial focus on treating the increasing number of patients refractory to current ADCs utilizing topoisomerase or microtubule inhibitor payloads, while subsequently, expanding the opportunity to be the first-line ADC of choice."

"The ADC landscape is rapidly evolving, and we believe the next wave of innovation will be driven not simply by new targets, but by novel payloads capable of overcoming the limitations of current treatments. That is precisely the opportunity we are pursuing with the PH1 payload," continued Mr. Gaslightwala. "With continued execution towards Phase 1 and unique collaborations as announced with Whitehawk Therapeutics, we believe Akari is increasingly well positioned to accelerate the value and impact of our differentiated ADC payload technology."

Third Quarter and Recent Strategic Highlights

Advancing AKTX-101 Towards Planned Phase 1 Initiation in 2027

Initiated GLP toxicology studies for AKTX-101, Akari’s lead TROP2-targeted ADC utilizing its proprietary PH1 payload, representing an important milestone in the Company’s transition toward clinical-stage development.
Continued IND-enabling activities, including required non-clinical and CMC/manufacturing work needed to file an IND to support Phase 1 clinical studies by mid-2027.
Announced collaboration with Whitehawk Therapeutics to explore the development of a novel dual payload construct for an ADC utilizing Akari’s PH1 payload, supporting the Company’s broader strategy of working with partners to further unlock the potential of the PH1 ADC payload.
New Preclinical Data Reinforce PH1’s Potential to Address ADC Therapy Resistance

Akari reported new preclinical findings demonstrating encouraging anti-tumor activity of AKTX-101 across multiple clinically relevant urothelial cancer models, including settings where existing ADC therapies showed limited effectiveness.

Key findings included:

Statistically significant tumor growth inhibition compared with vehicle in the UM-UC-14 advanced urothelial carcinoma model, in which Padcev (enfortumab vedotin) showed limited activity.
Encouraging activity in a tumor model of acquired resistance to Trodelvy (sacituzumab govitecan), a first-generation TROP2-targeted ADC, with Trodelvy resistant tumors slowing in growth after being switched to AKTX-101.
These findings provide important preclinical support for the potential of AKTX-101 to offer a differentiated therapeutic approach in cancers with limited responsiveness to existing ADCs. The results also support further investigation of PH1-based ADCs as potential treatment options following progression on currently available therapies.

"AKTX-101 showed encouraging activity in an advanced urothelial cancer model in which Padcev had limited activity, and slowed tumor growth in a separate model after tumors developed resistance to Trodelvy," said Satyajit Mitra, Executive Director, Head of Oncology at Akari Therapeutics. "Together, these findings support further evaluation of AKTX-101 after progression on prior ADC therapy. The Trodelvy findings also reinforce our hypothesis that a different payload mechanism may help address payload-specific resistance while retaining the same TROP2 target."

Expanding the Pipeline and Intellectual Property Estate of the PH1 Payload Platform

Continued early discovery work for AKTX-102, the Company’s CEACAM5-targeted ADC candidate utilizing PH1.
Expanded intellectual property protection through the filing of international patent application PCT/US2026/45955, covering PH1’s modulation of alternative RNA splicing pathways implicated in tumor growth, survival and therapeutic resistance.
The patent application builds on preclinical findings demonstrating PH1-mediated modulation of cancer-associated pathways, including VEGF-A, FAS and androgen receptor splice variants.
Akari’s strategy extends beyond a single drug candidate. By establishing PH1 as a potentially versatile ADC payload, the Company is pursuing opportunities to create value through both internally developed programs and external strategic collaborations, with the potential to broaden the platform’s application without relying exclusively on Akari-funded clinical development.

Strengthening Business Development Capabilities to Capitalize on Strategic Opportunities

In October 2026, Akari appointed Vatnak Vat-Ho as Chief Business Officer, further strengthening the Company’s ability to pursue strategic partnerships, licensing arrangements and corporate development opportunities.

Mr. Vat-Ho brings more than 20 years of experience in oncology business development, biopharmaceutical strategy and capital markets, including involvement in transactions totaling more than $25 billion in aggregate value.

His experience includes originating and executing ADC payload collaborations involving Exelixis and BioNTech, providing relevant expertise as Akari seeks to expand the reach of its PH1 platform through potential strategic partnerships.

Upcoming Development Priorities and Potential Value Drivers

Akari remains focused on executing a series of development and strategic initiatives designed to advance its lead candidate and expand the potential applications of its proprietary PH1 payload.

AKTX-101 Clinical Advancement: Progress in GLP toxicology, GMP manufacturing and remaining IND-enabling activities toward planned Phase 1 clinical development in mid-2027.
Strengthening Scientific Platform: Continue generating evidence demonstrating PH1’s differentiated activity in tumors resistant to existing ADC therapies.
Business Development and Strategic Partnerships: Advance ongoing collaborations and evaluate licensing and business development opportunities that could expand PH1’s application to new ADC molecules, as well as novel ADC constructs like dual payloads built around PH1.
Internal Pipeline Expansion: Continue to advance PH1-based ADC candidates targeting additional tumor-associated antigens, including the CEACAM5-targeted AKTX-102.
Summary of Financial Results for Third Quarter 2026

The Company closed the third quarter with $5.7 million in cash, the second highest cash balance since 2024. Operating expenses were $4.7 million, compared to $7.4 million for the comparable period in 2025. The Company received proceeds of approximately $2.9 million from the exercise of previously issued warrants and repaid in full its $0.7 million of outstanding convertible notes.

Research and development expenses were approximately $2.1 million for the three months ended September 30, 2026, compared to approximately $0.2 million for the comparable period in 2025. This reflects the Company’s increased investment in advancing its ADC development platform and related research and development activities.

General and administrative expenses were approximately $2.6 million for the three months ended September 30, 2026, compared to approximately $2.0 million for the comparable period in 2025. The increase was primarily attributable to higher professional fees and a one-time cost associated with the termination of an agreement with a prior placement agent.

Loss from operations was approximately $4.7 million for the three months ended September 30, 2026, compared to approximately $7.4 million for the comparable period in 2025. The prior-year quarter included a $5.2 million impairment charge related to the Company’s former PHP-303 program.

Net loss was approximately $4.8 million for the three months ended September 30, 2026, compared to approximately $6.4 million for the comparable period in 2025.

Cash totaled approximately $5.7 million as of September 30, 2026, compared to approximately $5.2 million as of December 31, 2025. The Company reported net cash used in operating activities of approximately $9.8 million for the nine months ended September 30, 2026. During the third quarter of 2026, the Company received approximately $2.9 million in proceeds from the exercise of outstanding warrants. The Company also repaid in full its $0.7 million of outstanding convertible notes at their August 31, 2026 maturity and had no convertible notes or notes payable outstanding as of September 30, 2026.

(Press release, Akari Therapeutics, NOV 12, 2026, View Source [SID1234674659])