Akari Therapeutics Issues 2025 End of Year Letter to Shareholders

Rhea-AI Summary

Akari Therapeutics (Nasdaq: AKTX) issued its 2025 end-of-year letter outlining progress advancing antibody drug conjugates (ADCs) built on its proprietary PH1 payload, a spliceosome-modulating mechanism. Key 2025 milestones include: initiation of GMP manufacturing with WuXi XDC to support clinical supply, filing three new patents on the PH1 payload in H2 2025, preclinical activity of lead ADC AKTX-101 across pancreatic (KRAS), urothelial, gastric and AR-V7 prostate models, and differentiated safety in non-human primates. Akari plans regulatory interactions and aims to submit IND/CTA enabling a Phase 1 start in late 2026 or early 2027, subject to regulatory clearance.

Positive

• Initiated GMP manufacturing with WuXi XDC to produce clinical-grade AKTX-101
• Filed three new patents for the PH1 payload in the last two quarters of 2025
• AKTX-101 showed preclinical activity in KRAS-driven pancreatic, urothelial, gastric and AR-V7 prostate models
• Non-human primate data indicate a differentiated safety profile versus conventional Trop2 ADCs

Negative

• Planned Phase 1 timing (late 2026/early 2027) is subject to regulatory clearance and not guaranteed
• All efficacy data cited remain preclinical; no clinical (human) data yet to validate safety or efficacy

News Market Reaction

+2.29%

5 alerts

+2.29% News Effect

+15.6% Peak Tracked

-8.0% Trough Tracked

+$296K Valuation Impact

$13M Market Cap

0.3x Rel. Volume

On the day this news was published, AKTX gained 2.29%, reflecting a moderate positive market reaction. Argus tracked a peak move of +15.6% during that session. Argus tracked a trough of -8.0% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $296K to the company's valuation, bringing the market cap to $13M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patents Filed: 3 new patents Phase 1 Timing: Late 2026 or early 2027 Phase 1 Enabling: Phase 1 +5 more

8 metrics

Patents Filed 3 new patents Provisional patent filings around PH1 payload in last two quarters of 2025

Phase 1 Timing Late 2026 or early 2027 Planned first-in-human AKTX-101 trial start, subject to regulatory clearance

Phase 1 Enabling Phase 1 GMP manufacturing of clinical-grade AKTX-101 to support first-in-human study

Conference Ranking Top 150 submissions SITC immuno-oncology data submission recognition in 2025

Year 2025 End-of-year shareholder letter summarizing strategic and scientific progress

Cancer Types Pancreatic, lung, colon, urothelial, gastric, prostate Preclinical activity shown for AKTX-101/PH1 across multiple tumor models

IND/CTA Submission Timing End of 2026 / early 2027 Targeted timing to enable IND/CTA filings for AKTX-101

Scientific Advisory Board World-class board New advisors to guide PH1 ADC strategy, details forthcoming

Market Reality Check

Price: $0.2330 Vol: Volume 727,947 vs 20-day ...

low vol

$0.2330 Last Close

Volume Volume 727,947 vs 20-day average 2,640,173 (relative volume 0.28x) shows limited trading interest ahead of this shareholder letter. low

Technical Shares at $0.2615 are trading below the 200-day MA of $0.96 and remain 84.88% under the 52-week high of $1.73.

Peers on Argus

Peer biotech names show mixed moves, with QTTB, KZR and ALLR modestly higher whi...

1 Up

Peer biotech names show mixed moves, with QTTB, KZR and ALLR modestly higher while RNTX and LIXT are lower, and only NRXS flagged on momentum up 8.1%. This pattern suggests today’s setup around AKTX is more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Dec 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 23	GMP manufacturing	Positive	-7.1%	Started GMP manufacturing of AKTX-101 with WuXi XDC for Phase 1 support.
Dec 18	Investor outreach	Positive	-2.2%	Released virtual investor segment detailing PH1 payload and AKTX-101 plans.
Dec 16	Equity financing	Negative	-38.3%	Announced ~$5M registered direct and private placement with warrant coverage.
Dec 09	Preclinical data	Positive	+3.2%	Reported AKTX-101 potency and superiority vs daraxonrasib in PDAC models.
Dec 04	Corporate update	Positive	+1.6%	CEO Corner outlined PH1 ADC platform and plan for 4Q 2026 clinical entry.

Pattern Detected

Recent news shows positive R&D and corporate updates often aligning with modest gains, while equity financings have drawn sharp selling. One notable divergence occurred when GMP manufacturing news coincided with a negative price reaction.

Recent Company History

Over the past month, Akari has steadily built its ADC story around PH1 and lead candidate AKTX-101. A Dec 4 CEO Corner introduced the ADC payload platform and plans for IND-enabling studies, followed by Dec 9 preclinical data in hard-to-treat KRAS-mutant pancreatic cancer. Subsequent financing on Dec 16–17 raised cash but triggered a steep selloff. Recent GMP manufacturing and investor education updates reinforced plans for a first-in-human trial in late 2026/early 2027, which this year-end letter reiterates and contextualizes.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-07-29

Akari has an active S-3 shelf registration dated 2025-07-29, with at least two prospectus supplements filed on 2025-10-16 and 2025-12-17. This framework has supported recent capital raises and could facilitate additional registered offerings before shelf expiry on 2028-07-29.

Market Pulse Summary

This announcement recaps Akari’s 2025 transition toward oncology ADCs built around its PH1 payload a...

Analysis

This announcement recaps Akari’s 2025 transition toward oncology ADCs built around its PH1 payload and lead candidate AKTX-101, highlighting GMP manufacturing, new patents, and SITC data. Investors may track progress toward regulatory interactions, CMC completion, and the targeted late 2026/early 2027 Phase 1 start, while weighing recent equity financings, going-concern language in filings, and ongoing Nasdaq listing compliance as key risk factors.

Key Terms

antibody drug conjugates, adcs, payload, spliceosome-modulating, +4 more

8 terms

antibody drug conjugates medical

"an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads"

Antibody drug conjugates are targeted medicines that combine an antibody, which seeks out specific markers on diseased cells, with a powerful drug that is released only when the antibody binds its target. Think of it as a guided missile that delivers a toxic payload directly to its target, reducing damage to healthy cells; investors watch them because successful ADCs can offer high-value, niche treatments and drive strong revenue and patent-based protection for developers.

adcs medical

"developing antibody drug conjugates (ADCs) with novel payloads today issued the following letter"

Antibody-drug conjugates (ADCs) are targeted cancer medicines that combine an antibody, which seeks out specific markers on tumor cells, with a powerful drug payload that is released once the antibody binds its target. Think of them as a guided missile that delivers a toxic package directly to diseased cells to limit harm to healthy tissue. Investors watch ADC news closely because clinical trial results, manufacturing complexity and regulatory decisions can sharply change a biotech company’s value.

payload medical

"a new class of ADCs with a Novel Payload, PH1"

Payload is the active substance or cargo carried by a delivery system — for example, the drug molecule attached to an antibody, the gene in a viral vector, or instruments aboard a satellite. Investors care because the payload determines the product’s therapeutic effect, safety profile, manufacturing complexity, regulatory hurdles and commercial value; like the contents of a sealed package, the delivery method matters, but the payload is what buyers ultimately want.

spliceosome-modulating medical

"our proprietary PH1 payload, a spliceosome-modulating mechanism"

Spliceosome-modulating describes drugs or therapies that alter the spliceosome, the cell’s machinery that cuts and joins pieces of messenger RNA before it becomes a protein. Like changing how a film editor cuts scenes, these treatments can change which protein versions a cell makes, potentially correcting genetic errors or blocking cancer growth. For investors, this signals a high-science approach with the potential for big clinical gains but also greater development risk and dependence on precise patient selection.

trop2 medical

"AKTX-101 is a Trop2 targeted ADC that delivers the PH1 payload"

Trop2 is a protein found on the surface of many cancer cells that acts like a visible flag doctors and drugmakers can use to find and attack tumors. It matters to investors because drugs designed to bind Trop2 can deliver treatment directly to cancer cells, affecting how well a therapy works, which patients it helps, and the potential market and regulatory value of companies developing those targeted treatments.

non-cleavable linker medical

"PH1 payload using a proprietary non-cleavable linker designed to drive potent tumor cell killing"

A non-cleavable linker is a chemical “glue” used in targeted medicines to hold a targeting molecule (like an antibody) and a toxic drug together so the pair stays intact instead of falling apart inside the body. For investors, it matters because this design increases stability in circulation, can reduce off-target side effects, and influences how and where the active drug is released—affecting safety, dosing, and potential market value of the therapy.

gmp technical

"begin manufacturing GMP-grade clinical product for AKTX-101 to support our future clinical studies"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

cmc technical

"Completion of CMC and non-clinical work for AKTX-101 to enable IND/CTA submissions"

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

AI-generated analysis. Not financial advice.

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

FAQ

What is Akari Therapeutics announcing for AKTX (AKTX) in late 2025?

Akari reported 2025 progress including GMP manufacturing with WuXi XDC, three PH1 patent filings, preclinical AKTX-101 data, and plans for a Phase 1 in late 2026/early 2027.

When does Akari plan to start the AKTX-101 Phase 1 trial (AKTX)?

Akari aims to initiate the Phase 1 trial in late 2026 or early 2027, pending regulatory clearance and completion of CMC/non-clinical work.

What cancers did AKTX-101 show preclinical activity against in 2025?

AKTX-101 demonstrated preclinical activity in KRAS-driven pancreatic models, urothelial (bladder), gastric, and AR-V7 prostate models.

What does the WuXi XDC partnership mean for AKTX-101 development?

The WuXi XDC agreement establishes GMP production of clinical-grade AKTX-101 to support IND/CTA-enabling studies and a planned Phase 1.

How many patents did Akari file for the PH1 payload in 2025 (AKTX)?

Akari filed three new patents around the PH1 ADC payload within the last two quarters of 2025.

Does Akari have human clinical data for AKTX-101 as of Dec 30, 2025 (AKTX)?

No; all efficacy and safety results reported are preclinical, with first-in-human studies planned after regulatory clearance.