Akari Therapeutics Releases CEO Corner Highlighting Strategic Progress and Path to Clinical Development Under CEO Abizer Gaslightwala

Rhea-AI Summary

Akari Therapeutics (Nasdaq: AKTX) released a CEO Corner from Abizer Gaslightwala reviewing his first year and strategic progress toward clinical development.

Highlights include advancement of the PH1 ADC payload platform, lead program AKTX-101 (Trop2-targeted) with a non-cleavable linker, initiation of IND-enabling activities with WuXi XDC, a target IND/CTA filing goal in late 2026 or early 2027, introduction of AKTX-102 targeting CEACAM5, multiple provisional patent filings, and formation of a scientific advisory group.

Positive

• Initiation of IND-enabling activities with WuXi XDC
• AKTX-101 progressed toward clinical readiness (Trop2-targeted ADC)
• Pipeline expanded with AKTX-102 targeting CEACAM5 tumors
• Strengthened IP via multiple provisional patent filings

Negative

• IND/CTA timing is contingent on regulatory clearance
• Advancement remains at preclinical stage without human data yet
• Operational progress depends on external manufacturing partner execution

Key Figures

Planned IND/CTA timing: Late 2026 or early 2027 Phase 1 study: Phase 1 CEO tenure: First year +1 more

4 metrics

Planned IND/CTA timing Late 2026 or early 2027 Target timing to submit IND or CTA for AKTX-101

Phase 1 study Phase 1 Planned first-in-human clinical study for AKTX-101

CEO tenure First year CEO Corner reflects on Abizer Gaslightwala’s first year leading Akari

SITC presentation year 2025 Preclinical PH1 data presented at 2025 Society for Immunotherapy of Cancer

Market Reality Check

Price: $0.2567 Vol: Volume 46,639 vs. 20-day ...

low vol

$0.2567 Last Close

Volume Volume 46,639 vs. 20-day average 249,470 (relative volume 0.19) signals limited pre-news participation. low

Technical Shares at 0.2567, well below 200-day MA of 0.71 and 85.16% under the 52-week high, though 17.86% above the 52-week low.

Peers on Argus

Biotech peers show mixed momentum: scanner names include one stock up 5.11% and ...

1 Up 2 Down

Biotech peers show mixed momentum: scanner names include one stock up 5.11% and two down as much as 4.38%, with sector summary citing a median move of -3.5%, pointing to broader group dynamics rather than an isolated move.

Previous Clinical trial Reports

2 past events · Latest: Dec 23 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
Dec 23	GMP manufacturing start	Positive	-7.1%	Initiated GMP manufacturing of AKTX-101 with WuXi XDC for Phase 1 support.
Sep 24	Preclinical data update	Positive	+46.0%	Promising PH1 preclinical data showing activity in prostate cancer models.

Pattern Detected

Clinical-trial-related news has produced mixed reactions: one strong positive move and one notable selloff, suggesting inconsistent trading responses to similar catalysts.

Recent Company History

Recent clinical-trial-tagged updates for Akari centered on advancing AKTX-101 and its PH1 ADC payload. In September 2025, promising preclinical PH1 data for prostate cancer coincided with a 45.96% gain. By December 2025, initiating GMP manufacturing with WuXi XDC to support a planned Phase 1 first-in-human trial was followed by a -7.08% move. Today’s CEO Corner continues this path-to-clinic narrative, emphasizing IND-enabling progress and pipeline expansion.

Historical Comparison

+19.4% avg move · In the last two clinical-trial-tagged updates, AKTX moved an average of 19.44%. This CEO Corner simi...

clinical trial

+19.4%

Average Historical Move clinical trial

In the last two clinical-trial-tagged updates, AKTX moved an average of 19.44%. This CEO Corner similarly focuses on AKTX-101’s path toward first-in-human studies and broader PH1 platform development.

Clinical narrative has progressed from PH1 preclinical efficacy, to GMP manufacturing for AKTX-101, to current IND-enabling and planned Phase 1 work.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-07-29

The company has an effective S-3 shelf registration filed on 2025-07-29, with documented usage via 424B5 takedowns in October and December 2025, indicating an established mechanism for future capital raises if needed.

Market Pulse Summary

This announcement underscores Akari’s evolution toward a clinical-stage ADC company, highlighting AK...

Analysis

This announcement underscores Akari’s evolution toward a clinical-stage ADC company, highlighting AKTX-101’s IND-enabling work, a planned Phase 1 trial in late 2026 or early 2027, and expansion with AKTX-102. Historically, clinical-trial-tagged updates have triggered both strong gains and selloffs, reflecting sensitivity to execution milestones. Investors may watch for IND or CTA submissions, Phase 1 initiation, capital-raising activity under the S-3 shelf, and additional PH1 data as key markers of progress.

Key Terms

antibody drug conjugates, adcs, immuno-oncology, ind-enabling, +4 more

8 terms

antibody drug conjugates medical

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

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 immuno-oncology payloads"

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.

immuno-oncology medical

"developing antibody drug conjugates (ADCs) with novel immuno-oncology payloads"

Immuno-oncology is a field of medicine focused on using the body's immune system to fight cancer. It involves developing treatments that help the immune system recognize and attack cancer cells more effectively. For investors, advancements in immuno-oncology can signal promising new therapies that may lead to improved patient outcomes and potentially significant commercial opportunities.

ind-enabling regulatory

"A key step toward clinical advancement came with the initiation of IND-enabling activities"

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.

trop2 medical

"Akari’s lead program, AKTX-101, is a Trop2-targeted ADC powered by 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.

ceacam5 medical

"AKTX-102, targeting CEACAM5-expressing tumors. By combining a novel antibody construct"

A protein found on certain cells and released into the blood that often becomes elevated in some cancers; it is commonly measured as a tumor marker. Think of it as a biological flag or smoke signal that can help doctors detect, monitor disease progression, or judge whether a therapy is working. For investors, levels and uses of this marker matter because they influence diagnostics, drug development, patient selection, regulatory decisions, and commercial markets.

first-in-human medical

"plans to initiate a first-in-human Phase 1 clinical study shortly thereafter"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

phase 1 medical

"plans to initiate a first-in-human Phase 1 clinical study shortly thereafter"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

AI-generated analysis. Not financial advice.

Highlights strategic progress achieved under Abizer Gaslightwala’s leadership, including advancement of AKTX-101 and expansion of Akari’s ADC pipeline 

Access the Akari CEO Corner here

TAMPA, Fla. and LONDON, March 13, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel immuno-oncology payloads, today released a new CEO Corner segment featuring President and Chief Executive Officer Abizer Gaslightwala reflecting on his first year leading the Company and the strategic progress achieved during that time.

Over the past year under Abizer Gaslightwala’s leadership, Akari Therapeutics has sharpened its strategic focus and advanced the development of its proprietary PH1 ADC payload platform. In the latest CEO Corner, Mr. Gaslightwala highlights the key scientific, operational and strategic milestones achieved as the Company positions itself to transition to a clinical stage biotechnology company.

The Company’s lead program, AKTX-101, is a Trop2-targeted ADC powered by the PH1 payload and engineered with a proprietary non-cleavable linker. Under Mr. Gaslightwala’s leadership, Akari has expanded the scientific understanding of its PH1 platform through new preclinical data presentations at leading scientific conferences, including the 2025 Society for Immunotherapy of Cancer (SITC), where the novel immuno-oncology effects of the payload were presented. 

A key step toward clinical advancement came with the initiation of IND-enabling activities through a strategic manufacturing partnership with WuXi XDC, a leading global ADC development and manufacturing partner. This collaboration supports Akari’s goal of submitting an IND or CTA for AKTX-101 in late 2026 or early 2027, with plans to initiate a first-in-human Phase 1 clinical study shortly thereafter, subject to regulatory clearance.

During this period of strategic advancement, Akari also expanded its pipeline with the introduction of AKTX-102, targeting CEACAM5-expressing tumors. By combining a novel antibody construct with the PH1 payload, the Company aims to unlock one of oncology’s historically challenging targets and demonstrate the scalability of its “pipeline in a payload” strategy.

In parallel, the Company strengthened its intellectual property estate through multiple provisional patent filings covering aspects of the PH1 payload, immune system activation mechanisms, antibody design innovations and potential combination strategies. Akari also established a world-class group of scientific advisors from leading cancer research institutions to support the advancement of its platform.

The CEO Corner segment is now available here.

About Akari Therapeutics

Akari Therapeutics is an oncology biotechnology company developing next-generation antibody drug conjugates (ADCs) with a unique payload, PH1, which targets RNA splicing. 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 antigen target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, enabling it to deliver its novel PH1 payload directly into the tumor with minimal off-target effects. 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 both the innate and adaptive immune system 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. The PH1 payload has also been demonstrated to be very active against cancer cells with key oncogenic drivers such as KRAS, BRAF, ARV7, FGFR3 fusions, and others. The Company has initiated IND enabling studies for AKTX-101 with a goal of starting its First-In-Human trial by late 2026/early 2027. Akari is also developing AKTX-102, an ADC candidate targeting CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-validated tumor antigen broadly expressed across multiple solid tumors. AKTX-102 is designed to leverage Akari’s proprietary PH1 spliceosome-modulating payload and novel antibody construct to enable differentiated tumor cell killing and immune activation.

For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
AKTX@jtcir.com

FAQ

What clinical timeline did Akari Therapeutics (AKTX) give for AKTX-101?

Akari expects to target an IND or CTA filing in late 2026 or early 2027. According to the company, IND-enabling activities have been initiated with WuXi XDC to support that filing and a first-in-human Phase 1 study thereafter, subject to regulatory clearance.

What is AKTX-101 and how is it engineered by Akari (AKTX)?

AKTX-101 is a Trop2-targeted ADC powered by the PH1 payload with a non-cleavable linker. According to the company, it combines the PH1 immuno-oncology payload and proprietary linker design to advance toward clinical evaluation.

What new program did Akari (AKTX) add to its pipeline in March 2026?

Akari introduced AKTX-102, an ADC targeting CEACAM5-expressing tumors. According to the company, AKTX-102 pairs a novel antibody construct with the PH1 payload to address a challenging oncology target and test the payload-led pipeline strategy.

What manufacturing partnership did Akari (AKTX) announce to support clinical plans?

Akari initiated IND-enabling activities through a strategic partnership with WuXi XDC. According to the company, the collaboration supports ADC development and manufacturing to enable an IND/CTA submission and subsequent Phase 1 initiation.

Has Akari (AKTX) disclosed clinical data for the PH1 payload yet?

No, disclosures to date are preclinical and conference presentations of data. According to the company, novel immuno-oncology effects were presented at scientific conferences, including SITC 2025, but first-in-human data are pending after regulatory clearance.

How has Akari (AKTX) protected its PH1 platform and technology?

Akari filed multiple provisional patents covering PH1 payload aspects, antibody design, and immune activation mechanisms. According to the company, these filings aim to strengthen intellectual property supporting the PH1 platform and potential combination strategies.