Akari Therapeutics Highlights Preclinical Data Demonstrating Therapeutic Potential of Lead Candidate, AKTX-101, for Hard-to-Treat K-Ras Mutant Pancreatic Cancer

Rhea-AI Summary

Akari Therapeutics (Nasdaq: AKTX) reported preclinical data showing its Trop2-targeting ADC AKTX-101 has single-digit nanomolar cytotoxic potency in K-Ras G12V pancreatic ductal adenocarcinoma (PDAC) cell lines and outperformed daraxonrasib in multiple PDAC cell lines.

The release notes Trop2 is highly expressed in K-Ras mutated PDAC, AKTX-101 carries a spliceosome-modulating payload PH1, and the company expects a first-in-human trial in late 2026 with preliminary safety and efficacy results in 2027.

Positive

• Single-digit nanomolar cytotoxic potency in K-Ras G12V PDAC cell lines
• AKTX-101 outperformed daraxonrasib in multiple PDAC cell lines
• Trop2 expression reported higher in K-Ras mutated PDAC versus wild-type
• Company plans first-in-human trial late 2026 with data in 2027

Negative

• Data are preclinical only; no clinical safety or efficacy demonstrated yet
• Therapeutic claims vs K-Ras G12V PDAC are unproven in humans
• High unmet-need disease with median overall survival ~1.4 years

Key Figures

K-Ras G12V driver share 1/3 of PDAC Proportion of pancreatic ductal adenocarcinoma driven by K-Ras G12V

Median overall survival 1.4 years Median OS in pancreatic cancer cited as significant unmet need

Annual diagnoses (U.S.) 60,000 people Estimated yearly U.S. pancreatic cancer diagnoses

Annual deaths (U.S.) 50,000 people Estimated yearly U.S. deaths from pancreatic cancer

FOLFIRINOX survival 1.5 years Overall survival with 5-FU containing FOLFIRINOX regimen

Gemcitabine+nab-paclitaxel survival 1.3 years Overall survival with gemcitabine plus nab-paclitaxel

Trial initiation timing late 2026 Expected start of first-in-human trial for AKTX-101

Preliminary data timing 2027 Planned preliminary safety and efficacy readout for AKTX-101

Market Reality Check

$0.3801 Last Close

Volume Volume 161,921 is well below the 20-day average of 1,025,331, indicating limited pre-news trading interest. low

Technical Shares at $0.34, about 80.35% below the $1.73 52-week high and above the $0.2918 52-week low.

Peers on Argus 1 Up 2 Down

Sector peers showed mixed moves pre-news: in momentum data, NEUP and QTTB were down around 5%, while ALLR was up over 4%. With no clear direction for AKTX and no same-day peer news, today’s announcement appears company-specific rather than part of a uniform sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Corporate update	Positive	+1.6%	CEO Corner outlining ADC payload platform and AKTX-101 development plans.
Nov 25	Corporate communication	Positive	+0.9%	CEO Corner segment highlighting PH1 payload and ADC discovery platform.
Nov 18	Management change	Positive	+12.0%	Appointment of experienced biotech finance leader as interim CFO.
Nov 10	Preclinical data	Positive	-1.6%	SITC preclinical immuno-oncology data for PH1 showing strong activity.
Nov 04	Conference abstract	Positive	+13.1%	SITC abstract describing PH1-driven immune activation in tumor models.

Pattern Detected

Recent Akari announcements, especially platform and executive updates, have more often coincided with positive price reactions than negative ones.

Recent Company History

Over the last month, Akari has focused communications on its ADC platform and lead candidate AKTX-101. A Nov 4 SITC abstract and a Nov 10 data presentation highlighted the PH1 payload’s immune activation, with mixed price reactions. Management changes and CFO appointment in mid‑November were followed by double‑digit gains. The Dec 4 CEO Corner reiterated plans to advance AKTX-101 toward clinical trials in 4Q 2026, setting the stage for today’s more tumor-specific preclinical data.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-29

The company has an active S-3 shelf registration dated 2025-07-29, expiring 2028-07-29, with at least one usage indicated by a 424B5 filing on 2025-10-16. The shelf is noted as not yet effective in the provided data, so any additional capital raises under this shelf would depend on effectiveness and further filings.

Market Pulse Summary

This announcement adds tumor-specific preclinical evidence for AKTX-101 in K-Ras G12V mutant PDAC, building on prior platform data and corporate updates. Investors may track progress toward the planned first-in-human trial in late 2026 and planned preliminary data in 2027, while weighing recent regulatory filings that note going-concern risks and financing needs alongside the scientific potential of Akari’s ADC and PH1 payload strategy.

Key Terms

trop2 medical

"Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines"

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.

adc medical

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

An antibody-drug conjugate (ADC) is a targeted cancer medicine that pairs an antibody that recognizes specific markers on tumor cells with a potent cell-killing drug, connected so the toxic payload is delivered directly to the cancer. For investors, ADCs matter because successful ADCs can improve patient outcomes and reduce side effects compared with traditional chemotherapy, shaping clinical trial success, regulatory approval chances, commercial demand, and a company’s valuation much like a guided missile versus a general bomb.

pancreatic ductal adenocarcinoma (pdac) medical

"The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma (PDAC)"

Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer, arising in the cells that line the small ducts which carry digestive juices. It behaves aggressively and is often diagnosed late, like a clogged pipe that causes widespread damage before it’s noticed. For investors, PDAC matters because its poor prognosis and limited approved treatments create a large unmet medical need—meaning successful new therapies can bring significant returns but carry high clinical and regulatory risk.

overall survival medical

"median overall survival (OS) is 1.4 years"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

k-ras g12v medical

"The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma"

A KRAS G12V mutation is a specific change in the KRAS gene where one building block is swapped so the cell’s KRAS protein gets stuck in an active state, driving uncontrolled cell growth in some cancers. For investors, it matters because this single-letter genetic change defines patient groups, influences how well targeted drugs or diagnostics work, and can determine the commercial size and regulatory risk of oncology treatments and tests.

k-ras inhibitors medical

"Current K-Ras inhibitors, such as Lumakras and Krazati, are only approved in K-Ras G12C mutated"

K-RAS inhibitors are drugs that block the activity of an abnormal KRAS protein found in some cancers, cutting off the faulty signal that tells tumor cells to grow and divide. For investors, they matter because successful inhibitors can transform treatment options, drive drug sales or acquisition interest, and materially affect the value of biotech firms, while clinical trial results, regulatory approvals or safety issues can rapidly change a company’s prospects — like turning a runaway machine on or off.

rna splicing medical

"the PH1 payload disrupts normal RNA splicing, a fundamental process cancer cells depend on"

RNA splicing is the cellular process that edits raw genetic messages (RNA) by cutting out unused segments and joining the useful pieces so a correct protein blueprint is produced—think of trimming and rearranging a draft recipe before cooking. For investors, it matters because mistakes or deliberate manipulations in splicing can cause or treat disease, create diagnostic markers, and serve as drug targets, affecting a biotech company’s therapeutic potential, regulatory risk, and commercial value.

cytotoxic potency medical

"AKTX-101 exhibited single digit nanomolar cytotoxic potency in all K-Ras G12V PDAC cell lines"

Cytotoxic potency measures how strongly a drug or chemical can kill or stop the growth of cells — like how concentrated a weed killer must be to eliminate plants. For investors, it signals likely effectiveness and the dose needed, which influence potential benefits, side effects, manufacturing costs and regulatory hurdles; higher potency can mean smaller doses and stronger results but also greater safety and development risk.

AI-generated analysis. Not financial advice.

Data highlights the ability of Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines in preclinical models, potentially addressing one of the most lethal cancers with the lowest survival rates 

The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer

Significant unmet need in pancreatic cancer where median overall survival (OS) is 1.4 years¹

TAMPA, Fla. and LONDON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced key preclinical data demonstrating the therapeutic potential of its novel ADC targeting Trop2, AKTX-101, in pancreatic cancer driven by K-Ras mutations, one of the deadliest and most treatment-resistant forms of cancer.

Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer², and about 50,000 people will die from this aggressive disease. The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, account for the vast majority of cases³ and have few effective treatment options, particularly for tumors driven by the K-Ras G12V mutation.

Current standard of care in K-Ras G12V-driven PDAC are 5-fluorouracil (5-FU) containing chemotherapy regimens such as FOLFIRINOX (Overall Survival = 1.5 years) or gemcitabine plus nab-paclitaxel (Overall Survival = 1.3 years), which offer poor outcomes, significant toxicities, and poor quality of life. Currently, there is a real void of targeted therapies for K-Ras driven PDAC, making this still one of the highest unmet need cancers. Current K-Ras inhibitors, such as Lumakras^® and Krazati^®, are only approved in K-Ras G12C mutated non-small cell lung cancer and colorectal cancer further emphasizing the void and the significant unmet need for K-Ras G12V targeted therapy options in PDAC patients.

AKTX-101 is an antibody-drug conjugate that delivers a novel RNA spliceosome modulating payload, PH1, into cancer cells that express Trop2 which is a protein commonly found at high levels in pancreatic and other hard-to-treat solid tumors. Once inside the tumor, the PH1 payload disrupts normal RNA splicing, a fundamental process cancer cells depend on to survive, grow, and spread. Trop2 is a ubiquitously expressed protein at high levels in PDAC and potentially a good ADC target⁴ in pancreatic cancer, and has been validated in other solid tumors including lung and breast cancers. Within pancreatic cancer, K-Ras mutated PDAC is associated with higher levels of Trop2 protein⁴ compared to PDAC with normal K-Ras, making a Trop2 ADC like ATKX-101 a potential precision therapeutic in this specific tumor mutation.

The latest data for AKTX-101 in KRas-G12V PDAC builds on preclinical evidence disclosed earlier in a patent filing. In this new study, AKTX-101 exhibited single digit nanomolar cytotoxic potency in all K-Ras G12V PDAC cell lines tested. Of significance, AKTX-101 also outperformed daraxonrasib in multiple PDAC cell lines (daraxonrasib is an investigational therapy being developed by Revolution Medicines to treat patients with cancers driven by K-Ras mutations).

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, “These preclinical data provide a rationale for Akari to develop AKTX-101 in areas of severe unmet need and historically very difficult cancers, such as K-Ras mutant PDAC. We aspire to tackle hard-to-treat cancers and are excited to see our novel spliceosome-modulating payload PH1, conjugated to an ADC, demonstrate activity against aggressive cancers like K-Ras mutant tumors.”

From this early data, the Company believes that AKTX-101 may have therapeutic potential to control an aggressive form of untreatable pancreatic cancer and its preliminary data support K-Ras G12V-mutated PDAC as another high unmet need opportunity for AKTX-101. These data continue to demonstrate the promise of the PH1 payload in treating some of the most difficult cancers like K-Ras mutant tumors.

The Company plans to present this preclinical data at an upcoming scientific conference and is currently advancing AKTX-101 towards a first-in-human trial, expected to initiate in late 2026, and preliminary safety and efficacy data in 2027. In parallel, the Company is pursuing discussions with potential partners on developing the PH1 payload for new ADCs targeting other antigens expressed in a range of cancer tumors. For more information, visit www.akaritx.com.

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. 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 Company’s need for additional capital; 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 

¹ Ebia et al 2025, https://doi.org/10.1200/PO-24-00684
² Siegel RL, et al. CA Cancer J Clin. 2024;74:12-49
³ Hallbrook CJ, et al. Cell. 2023;186:1729-1754
⁴ Mas et al 2023, https://doi.org/10.1016/j.clinre.2023.102108

FAQ

What preclinical activity did Akari report for AKTX-101 in K-Ras G12V PDAC (AKTX)?

AKTX-101 showed single-digit nanomolar cytotoxic potency in tested K-Ras G12V PDAC cell lines and outperformed daraxonrasib in multiple cell lines.

When does Akari expect to start the AKTX-101 first-in-human trial (AKTX)?

The company expects to initiate a first-in-human trial in late 2026, with preliminary safety and efficacy data in 2027.

What is the mechanism of AKTX-101 and its payload (AKTX)?

AKTX-101 is a Trop2-targeting ADC delivering the PH1 payload, which modulates the RNA spliceosome to disrupt cancer cell survival.

Why is AKTX-101 targeted to Trop2 for pancreatic cancer (AKTX)?

Trop2 is reported to be highly expressed in PDAC, and levels are higher in K-Ras mutated PDAC versus PDAC with normal K-Ras.

How does AKTX-101 compare to existing K-Ras inhibitors for PDAC (AKTX)?

Existing approved K-Ras inhibitors target G12C and are not approved for G12V PDAC; Akari reports AKTX-101 activity specifically in K-Ras G12V preclinical models.