| Source: Akari Therapeutics Plc
TAMPA, Fla. and LONDON, Dec. 30, 2025 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads today issued the following letter to shareholders from its President and Chief Executive Officer, Abizer Gaslightwala.
Dear Fellow Shareholders,
As 2025 concludes, I am pleased to reflect on a year of meaningful progress and significant achievements towards creating best-in-class ADCs to transform current cancer therapies. With each forward step and each new milestone, we are advancing our mission to bring our innovative and uniquely designed ADCs to cancer patients with the highest unmet needs. The scientific and operational strides made this year have positioned Akari for what we believe will be a pivotal and transformational year ahead for the Company.
2025: Building Our Foundation — A Year of Strategic Milestones and Execution
Advancing a New Class of ADCs with a Novel Payload, PH1
This year Akari solidified a clear scientific roadmap focused on progressing our innovative ADCs built on our proprietary PH1 payload, a spliceosome-modulating mechanism. This represents a fundamentally different approach compared to traditional ADC payloads, as PH1 was specifically designed to overcome key limitations of existing ADC payload classes by delivering:
- Potent cytotoxic activity to kill tumor cells without being vulnerable to traditional cancer resistant mechanisms affecting current ADC payloads
- Unique immune activation of both the innate and adaptive systems to broaden and deepen anti-tumor responses
- A differentiated safety profile compared to current ADCs with traditional payloads
These attributes align with Akari’s strategy to build ADC therapies that kill cancer cells directly and most importantly, harness and engage the powerful immune system to attack the cancer broadly. This 1-2 punch has been demonstrated to improve therapeutic durability, depth of response and remissions and significantly extend survival of preclinical models relative to current ADC therapies, which we believe will translate into superior outcomes for cancer patients in future clinical trials.
Progress on Lead Program: AKTX-101
Our lead program, AKTX-101, advanced significantly in 2025 with a number of key wins.
AKTX-101 is a Trop2 targeted ADC that delivers the PH1 payload using a proprietary non-cleavable linker designed to drive potent tumor cell killing, engage the immune system through both innate and adaptive responses to cancer tumors, and minimize off-target effects. We continued to build the preclinical data story and conviction for AKTX-101 and the PH1 payload as we prepare to enter clinical studies:
- AKTX-101 demonstrated significant activity in pancreatic cancer driven by KRAS, one of the most deadly mutations in pancreatic, lung and colon cancers.
- PH1 payload demonstrated significant activity against a key driver in prostate cancer, AR-V7, opening up future opportunities in this large patient population.
- These data build on the powerful results for AKTX-101 that demonstrate compelling activity in both urothelial (bladder) and gastric cancer preclinical models.
- The safety profile of AKTX-101, as tested in non-human primates, highlights clear differentiation relative to current Trop2 ADCS that use conventional payloads, and suggests the potential for improved tolerability in clinical settings.
GMP Manufacturing Initiated with a World-Class Partner to Enable Upcoming Phase 1 Clinical Trials for AKTX-101
A watershed moment in 2025 was the initiation of our partnership with WuXi XDC to begin manufacturing GMP-grade clinical product for AKTX-101 to support our future clinical studies. WuXi XDC is a global leader in ADC development and manufacturing and has a track record for producing ADCs with the highest quality, speed and reliability for partners. This milestone is critical for Akari for a number of reasons:
- Marks the transition of Akari from a preclinical discovery company into a clinical focused biotechnology player
- Contributes to the production of high-quality, clinical-grade ADC for Phase 1 studies
- Signals confidence that one of the best global partners wants to work with Akari to advance its innovative ADC and payload into clinical trials
Akari believes that partnering with WuXi XDC enables it to quickly advance AKTX-101 toward first-in-human trials planned for late 2026 or early 2027, subject to regulatory clearance.
Intellectual Property and Scientific Engagement
Throughout 2025, we continued to bolster our intellectual property portfolio and the value of our payload platform with new provisional patent filings protecting the unique aspects of the PH1 payload. Of note, we filed three new patents around our ADC payload within the last two quarters of 2025, driven by the high productivity and efficiency of our research team.
Additionally, Akari presented promising immuno-oncology data at the most prominent immuno-oncology research meeting in the world, the Society for Immunotherapy Cancer (SITC). The submission was noted as one of the top 150 submissions at the conference, and garnered great enthusiasm and excitement from both academic researchers and pharmaceutical scientists on how splicing modulation via our PH1 ADC payload is a unique and effective way to attack cancer.
Finally, as we look to maximize the potential of our PH1 payload potential, we established a world-class Scientific Advisory Board to engage and guide Akari on our PH1 payload ADC strategy. These key advisors will play a critical role in helping us optimize how we develop our promising technology to maximize its impact in cancer patients moving forward. We plan on announcing more details about this group of well-known advisors in the near future.
Strengthening Our Operating Model
In parallel with the notable scientific and research advancements outlined, we took important steps in 2025 to strengthen Akari’s operating model and capital discipline. Our approach to capital infusions throughout 2025 enabled our R&D milestones noted previously, key patent filings, and the initiation of key manufacturing and preclinical activities to start the path to Phase 1 clinical studies with AKTX-101. These efforts also position the Company to pursue additional financing and partnership opportunities with both strategic investors and pharmaceutical/biotechnology companies as they also look at our upcoming catalysts and milestones with AKTX-101. We also made significant progress in reducing operating expenses post the close of the merger, while building our R&D capabilities through an efficient and scalable network of key vendors, consultants and suppliers.
Why 2026 Is Expected to Be a Transformational Year
Looking ahead, I am very excited to have Akari progressing to critical inflection points that could significantly increase the Company’s value and clinical impact:
Key Catalysts and Milestones on the Horizon
- Regulatory interactions with FDA for feedback on our planned Phase 1 trial
- Presentation of differentiating data on AKTX-101 vs other Trop2 ADCs
- Completion of CMC and non-clinical work for AKTX-101 to enable IND/CTA submissions at the end of 2026/ early 2027
- Initiation of the Phase 1 clinical trial in late 2026 or early 2027, subject to regulatory clearance
- Continued partnership discussions with pharmaceutical companies on our unique and differentiated PH1 payload/ADC approach and key catalysts forthcoming
Entering Phase 1 clinical studies will be a unique inflection point for Akari as an ADC oncology company, a milestone that historically correlates with increased visibility, investor interest and potential strategic partnerships with large pharmaceutical companies or strategic investors. Our excitement as a team for 2026 is unbounded, and we look forward to executing with urgency.
We remain grateful for your continued trust and support in our path forward as an oncology ADC company, and we are excited by the potential ahead. Thank you for your continued belief in our mission and focus on developing therapies that could make a significant difference for cancer patients in their continued fight. We look forward to updating you throughout 2026 as we work diligently and with impatience every day to bring innovative therapies to patients, and reward you as shareholders for your conviction and belief in our plan and execution.
Sincerely,
Abizer Gaslightwala
President & Chief Executive Officer
Akari Therapeutics, Plc
About Akari Therapeutics
Akari Therapeutics is an oncology biotechnology company developing next-generation spliceosome payload antibody drug conjugates (ADCs). Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, delivers its novel PH1 payload directly into the tumor. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome modulator designed to disrupt RNA splicing within cancer cells. This splicing modulation has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its novel payload PH1 to continue advancing its lead asset, as well as other undisclosed targets with this novel payload.
For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients; the Company’s targets, plans, objectives or goals for future operations, including those related to its product candidates. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; risks related to competition for the Company’s product candidates; and the Company’s ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
AKTX@jtcir.com
