AKTX 10-K & 10-Q changes, risk factors and insider trading
Akari Therapeutics Plc · Nasdaq · Pharmaceutical Preparations · CIK 1541157 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “The withdrawal of the United Kingdom from the EU (Brexit) could adversely affect our business, financial condition, results of operations and prospects.”
Removed heading “As of January 1, 2024, we were no longer a foreign private issuer and we are required to comply with the provisions of the Exchange Act, and the rules of Nasdaq, applicable to U.S. domestic issuers, which will continue to require us to incur significant expenses and expend time and resources.”
Removed heading “The rights of holders of our ADSs to participate in any future rights offerings may be limited, which may cause dilution to their holdings, and they may not receive cash dividends if it is impractical to make them available to them.”
Largest changes
“We have in the past received notices from The Nasdaq Stock Market relating to a failure to comply with the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in Listing Rule 5550(b) (the “Stockholders’ Equity Requirement”). Most recently, on November 24, 2025, we received a written notice from the Nasdaq Listing Qualifications, or the Notification Letter, notifying us that we were not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. …”see in full comparison
“As of January 1, 2024, we were no longer a foreign private issuer and we are required to comply with the provisions of the Exchange Act, and the rules of Nasdaq, applicable to U.S. domestic issuers, which will continue to require us to incur significant expenses and expend time and resources.”see in full comparison
“The rights of holders of our ADSs to participate in any future rights offerings may be limited, which may cause dilution to their holdings, and they may not receive cash dividends if it is impractical to make them available to them.”see in full comparison
U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensionssee in full comparisonbetweenaroundRussiathe world, including with respect to the March 2026 conflict in Iran involving the United States andUkraine as well as the ongoing conflict between Israel and Hamas.Israel. Although the length and impact of the ongoing military conflict is highly unpredictable, the conflicts could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain interruptions, which has led to high inflation globally. We are continuing to monitor inflation and global capital markets and assess the potential impacts on our business.
“The withdrawal of the United Kingdom from the EU (Brexit) could adversely affect our business, financial condition, results of operations and prospects.”see in full comparison
see in full comparisonMore recently, the closures of Silicon Valley Bank (“SVB”) and Signature Bank and their placement into receivership with the FDIC created bank-specific and broader financial institution liquidity risk and concerns. Although the Department of the Treasury, the Federal Reserve and the FDIC jointly released a statement that depositors at SVB and Signature Bank would have access to their funds, even those in excess of the standard FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term working capital needs, and create additional market and economic uncertainty. There can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market conditions.If the current equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term liquidity risk and make any necessary debt or equity financing more difficult, more costly, more onerous with respect to financial and operating covenants and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy and financial performance and could require us to alter our operating plans. In addition, there is a risk that one or more of our service providers, financial institutions, manufacturers, suppliers and other partners may be adversely affected by the foregoing risks, which could directly affect our ability to attain our operating goals on schedule and on budget.
Full comparison: every changed paragraph (189)
the costs of developing our current products and any future product candidates that we may develop, in-license or acquire;
the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
the costs and timing of future clinical trials or the need for additional clinical trials in any indications or product candidates which we are pursuing or may choose to pursue in the future;
the costs and timing of initiating manufacturing for our product candidates, including commercial manufacturing if any product candidate is approved;
the terms and timing of establishing and maintaining collaborations, license agreements and other partnerships;
the costs and timing of enhanced internal controls over financial reporting;
the effect of competing technological and market developments; and the costs associated with being a public company.
As
of December 31, 2024,2025, we had cumulative UK, U.S. federal, various U.S. state, Switzerland, and South Korea net operating loss carryforwards
(“NOL”) to offset future taxable income of approximately $145.7$153.2 million, $38.1$47.2 million, $71.8 million, less than $0.3$76.6 million, and $87.0$91.6 million, respectively. NOLs in certain jurisdictions do not expire, while NOLs in some jurisdictions are subject to expiration.
A lack of future taxable income would adversely affect our ability to utilize these NOLs. In addition, under Section 382 of the Internal
Revenue Code of 1986, as amended (the Code), a corporation that undergoes an “ownership change” is subject to limitations
on its ability to utilize its NOLs to offset future taxable income. We have already experienced ownership changes as defined under Section
382 of the Code. Depending on the timing of any future utilization of our NOLs, the amount that can be utilized each year may be limited
as a result of such previous ownership changes. In addition, future changes in our stock ownership, including changes that may be outside
of our control, could result in additional ownership changes under Section 382 of the Code. Our NOLs may also be impaired under similar
provisions of state law. We maintain a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty
of the ultimate realization of the future benefits of those assets.
As
a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such
internal control. Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”) requires that we evaluate and determine
the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met for management
to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.
In connection with our year-end assessment as part of the preparation of this Form 10-K, we determined that, as of December 31, 2024, 2025,
we did not maintain effective internal control over financial reporting due to material weaknesses identified relating to the lack of
formalized information technology general controls, lack of formally designed and implemented “purchase to pay” controls,
and lack of effective controls over business combination accounting, as more fully described in “Disclosure Controls and Procedures”
in Item 9A of Part II of this Form 10-K.10-K . A material weakness is a deficiency, or a combination of deficiencies, in internal control
over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated
financial statements will not be prevented or detected on a timely basis.
negative or inconclusive results from our preclinical trials, leading to a decision to conduct additional preclinical studies or abandon a program;
negative or inconclusive results from clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies or clinical trials or abandon a program;
our clinical safety data in humans not matching the safety evaluation in relevant animal models;
our strategy of deploying payloads, including our PH-1 payload, as ADCs failing to mitigate known toxicities of those classes of small molecules delivered as systemic chemotherapies;
our clinical data failing to match preclinical data supporting antibody selectivity, linker stability, pharmacokinetics, anti-tumor efficacy, or any other key attributes;
product-related side effects experienced by participants in our clinical trials or by individuals using drugs or therapeutic antibodies similar to ours;
delays in submitting IND applications or comparable foreign applications, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;
conditions imposed by the FDA, or other regulatory authorities regarding the scope or design of our clinical trials;
delays in clinical trials as a result of the limited number of patients with the diseases that some or all of our current or expected future product candidates target, patient enrollment taking longer than anticipated or patient withdrawal;
high drop-out rates or high failure rates of research subjects;
inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of preclinical studies or clinical trials;
greater-than-anticipated clinical trial costs;
poor effectiveness of our product candidates during clinical trials;
unfavorable FDA or other regulatory agency inspection and review of a clinical trial or manufacture site;
failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
delays and changes in regulatory requirements, policies and guidelines;
the FDA or other regulatory agencies interpreting our data differently than we do;
or adverse impacts caused by any future pandemics or geopolitical considerations which could heighten any of the foregoing risks.
Preclinical
and clinical drug development is a lengthy and expensive process, with uncertain timelines and outcomes. If preclinical studies or clinical
trials of our product candidates are prolonged or delayed, we may be unable to obtain required regulatory approvals,approvals and therefore be
unable to commercialize our product candidates or any of our future product candidates on a timely basis or at all.
clinical trial results may show the product candidates to be less effective than expected (for example, a clinical trial could fail to meet its primary or key secondary endpoint(s)) or have an unacceptable safety or tolerability profile;
failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis or application preparation, discussions with the FDA, EMA or other comparable foreign regulatory authorities (including FDA, EMA or other comparable foreign regulatory authorities requesting additional preclinical or clinical data, such as long-term toxicology studies), or encountering unexpected safety or manufacturing issues;
preclinical study results may show the product candidate to be less effective than desired or to have harmful on-target or off-target side effects; or the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized.
In
addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding
the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure
that our third-party providers comply) with current Good Manufacturing Practice (“cGMPs”) and Good Clinical Practice (“GCPs”)
for any clinical trials that we conduct post-approval. In addition, there is always the risk that we, a regulatory authority or a third
party might identify previously unknown problems with a product post-approval, such as AEs of unanticipated severity or frequency. Compliance
with these requirements is costly, and any failure to comply or other issues with our product candidatescandidates’ post-approval could adversely
affect our business, financial condition and results of operationsoperations.
design of the clinical trial protocol;
size and nature of the patient population;
eligibility criteria for the trial;
perceived risks and benefits of the product candidate under trial;
proximity and availability of clinical trial sites for prospective patients;
availability of competing therapies and clinical trials;
actual or threatened public health emergencies and outbreaks of disease;
clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;
efforts to facilitate timely enrollment in clinical trials;
number of physicians that treat patients with these diseases;
ability to identify and enroll such patients with a stage of disease appropriate for our ongoing or future clinical trials;
the costs of finding and diagnosing patients;
patient referral practices of physicians; and our ability to monitor patients adequately during and after treatment.
We
could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs overseeing the conduct of such trials,
by a Data Safety Monitoring Board for such trial or by the FDA, EMA, or other comparable foreign regulatory authorities. Such regulatory
authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in
accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA,
EMA, or other comparable regulatory foreign authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse
side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack
of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may
need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols
to IRBs for reexaminationre-examination and approval, which may impact the costs, timing or successful completion of a clinical trial.
To
date, we have not commenced or completed the evaluation of any of our current ADC candidates in human clinical trials. It is impossible
to predict when or if any product candidates we may develop will ultimately prove safe in humans. As is the case with pharmaceuticals
generally, it is likely that there may be side effects and AEs associated with our product candidates’ use. Often, it is not possible
to determine whether or not the product candidate being studied caused these conditions. Regulatory authorities may draw different conclusions
or require additional testing to confirm these determinations, if they occur. In addition, it is possible that as we test our product
candidates in larger, longer and more extensive clinical trials with a broader group of patients, or as use of these product candidates
becomes more widespread if they receive marketing approval, illnesses, injuries, discomforts and other AEs that were observed in earlier
trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by participants. In some instances,
certain side effects are only detectable after investigational product candidates are tested in large-scale, Phase 3 trials or after
they are made available to patients on a commercial scale after approval. If additional clinical experience indicates that any of our
current or future product candidates has serious or life-threatening side effects or other side effects that outweigh the potential therapeutic
benefit, the development of the product candidate may fail or be delayed, or, if the product candidate has received marketing approval,
such approval may be limited or revoked, which would harm our business, prospects, operating results and financial condition. If we elect,
or are required, to delay, suspend or terminate any clinical trial of our product candidates, the commercial prospects of our product
candidates may be harmed and our ability to generate revenue through their sale may be delayed or eliminated. Any of these occurrences
may harm our business, financial condition and prospects significantly Moreover, if our product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial value for the product candidate if approved. We may also be required to modify our trial plans based on findings after we commence our clinical trials. Many compounds that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the compound.significantly.
Moreover, if our product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial value for the product candidate if approved. We may also be required to modify our trial plans based on findings after we commence our clinical trials. Many compounds that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the compound.
regulatory authorities may suspend or withdraw approvals of any such product and require removal from the market;
regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies, specialty pharmacies and other pharmacy related distribution networks (for example, oncology therapies do have inherent risks and labeling considerations that in many instances require additional regulatory labeling requirements);
regulatory authorities may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a risk evaluation and mitigation strategy (REMS) plan to ensure that the benefits of the product outweigh its risks;
we may be required to change the way a product is administered, including changes in dosing regimens, frequency of dose, or reduction in dosing and may require us to conduct additional clinical trials or change the labeling of a product;
we may be subject to limitations on how we may promote the product leading to the potential for sales of the product to decrease significantly;
third-party private or government payors may not offer, or may offer inadequate, reimbursement coverage for our product candidates, or reimbursement payments may be delayed or impossible to recover; and we may be subject to litigation or product liability claims; and our reputation may suffer.
the product candidate may have unforeseen adverse side effects;
the time required to determine whether the product candidate is effective may be longer than expected;
fatalities arising during a clinical trial due to medical problems that may not be related to clinical trial treatments;
the product candidate may not appear to be more effective than standard of care therapies;
insufficient statistical power due to significant patient dropout or crossover to other therapies;
insufficient patient enrollment in the clinical trials; or we may not be able to produce sufficient quantities of the product candidate to complete the trials.
Management's Discussion & Analysis (MD&A)
New heading “AKTX-101 IND-Enabling Plan and Activities”
New heading “Scientific Disclosures – 2025 SITC Annual Meeting”
New heading “Intellectual Property – Expanding Protection Around PH1, Immune Activation, and Combination Strategies”
New heading “Leadership Updates”
New heading “Financing and Liquidity Initiatives”
New heading “ADS Ratio Change”
New heading “ADC discovery and pre-clinical development”
New heading “Impairment loss”
New heading “Merger-related expenses”
New heading “Restructuring and other expenses”
New heading “Gain on settlement of current liabilities”
New heading “Loss on debt extinguishment”
New heading “Loss on derivative liability”
New heading “October 2025 Financing”
New heading “White Lion Ordinary Share Purchase and Registration Rights Agreements”
New heading “August 2025 Financing”
New heading “Impairment Assessment of Goodwill and Other Intangible Assets”
Removed heading “Appointment of New President and Chief Executive Officer”
Removed heading “Pipeline Prioritization of the Merged Companies”
Removed heading “Restructuring and Reduction-in-Force”
Removed heading “Merger Agreement”
Removed heading “Bullous Pemphigoid (“BP”) clinical development (AK802)”
Removed heading “ADC preclinical development”
Removed heading “November 2024 Private Placement”
Removed heading “May 2024 Private Placement”
Removed heading “May 2024 Convertible Notes”
Removed heading “March 2024 Private Placement”
Removed heading “September 2023 Private Placement”
Removed heading “March 2023 Registered Direct Offering”
Removed heading “Research and development prepayments, accruals and related expenses”
Removed heading “Intangible Assets Impairment”
Largest changes
“Impairment Assessment of Goodwill and Other Intangible Assets”see in full comparison
“In no event may the Company issue to the Purchaser under the ELOC Purchase Agreement more than 13,039,369,358 Ordinary Shares (the “Exchange Cap”), which equals 19.99% of the Company’s outstanding Ordinary Shares as of the Execution Date, unless the Company obtains shareholder approval to issue shares in excess of the Exchange Cap or the average price paid for all Ordinary Shares issued under the agreement is equal to or greater than the Minimum Price (as defined in the ELOC Purchase Agreement). …”see in full comparison
“If the Company concludes that it is more likely than not that the fair value of the asset or the reporting unit is less than its carrying value, or if the Company elects to bypass the qualitative assessment, a quantitative impairment test is performed. The quantitative test compares the fair value of the asset or reporting unit with its carrying amount. If the carrying amount of the asset or a reporting unit exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. …”see in full comparison
Full comparison: every changed paragraph (177)
We are an oncology company developing next generation ADCs designed around novel payload biology. Our platform is anchored by PH1, a spliceosome modulating payload that in preclinical settings has demonstrated cytotoxic activity and robust activation of the immune system to attack cancer. Our business is focused on advancing our lead program, AKTX-101, through IND enabling activities and clinical readiness while maintaining the ability to expand the PH1 based ADC pipeline, as capital and priorities permit. We also have a second program, including AKTX-102, a CEACAM5 directed ADC, program, that is earlier in development.
We are an oncology company developing next-generation ADCs designed around novel payloads, which we believe may have the potential to transform the efficacy and safety outcomes of ADCs as cancer therapies beyond options that are currently available or in development.
ADCs
are a class of cancer therapies that combine the precision targeting of antibodies with payload toxins that attack cancer cells. To date,
innovation in the field of ADC therapies has focused primarily on the development of novel antibodies linked to existing classes of payload
toxins. For example, there is a range of approved ADCs with antibodies that target the Her2, Trop2,Trop-2, CD19, CD22, CD30, Nectin-4, Tissue
Factor, and FR alpha antibodies. But there is a surprising lack of diversity in the payload toxins to which those antibodies are linked,
as all of these marketed products, and more than 90% of ADCs in late-stage clinical development of which we are aware, utilize payloads
from just two standard classes: (1) microtubule inhibitors or (2) DNA-damaging agents such as topoisomerase I inhibitors.
Our ADC Platform enables us to generate a range of ADC product candidates that pair our novel payloads with biologically validated antibody targets prevalent in cancer tumors. We believe that our focus on the development of ADCs that utilize our novel payloads may allow us to develop ADCs with potential benefits that include:
more effective cancer-killing properties, or cytotoxicity;
generation of greater numbers of neoepitopes than currently available ADCs, leading to activation of both B-cells and T-cells in the tumor microenvironment to generate an immune response that has the potential to continue to kill cancer cells in the tumor microenvironment and throughout the body;
ability to be used in combination with checkpoint inhibitors to potentially deliver synergistic efficacy results (more than additive);
sustained duration of response of tumor regression or elimination;
reduced tumor resistance; and improved safety and tolerability relative to ADCs that are currently available.
Our
lead product candidate is AKTX-101, a preclinical stage Trop2-targetingTrop-2-targeting ADC that combines PH1 with thea Trop2Trop-2 antibody,targeting whichantibody. Trop-2
is an antigen that is expressed in the highesta number of highly incident solid tumor cancer types,tumors, including lung, breast, colonbladder, head and prostate.neck, gastric,
pancreatic, colon, prostate, and others. We aim to establish AKTX-101 as a best-in-class Trop2-targetingTrop-2-targeting ADC for the treatment of a
variety of solid tumors.
We
acquired the proprietary rights to our ADC discovery and development platform in connection with the Merger. Prior to that time, we were
primarily focused on advancing our former product candidates nomacopan and PAS-nomacopan (longer-acting nomacopan that is PASylated).
Since the closing of the Merger, we have focused substantially all of our efforts on the development of ADCs and our ADC Platform. We
have suspended further internal development of our legacy programs, nomacopan and PAS-nomacopan, and intend to seek strategic partners
to advance their development externally. ForOur ouractivities PHP-303since program,inception ahave program that Peak Bio had advanced prior to the closingconsisted of theperforming Merger,research we intend to seek strategic partners for it as well to further itsand development externally.activities
and raising capital.
Our activities since inception have consisted of performing research and development activities and raising capital.
During 2025 and through the date of this Annual Report on Form 10-K, we invested key scientific, operational, leadership, and capital resources to support the continued development of our ADC platform and the advancement of our lead program, AKTX-101. The developments summarized below include scientific disclosures and conference presentations related to our PH1 payload and its proposed immuno-oncology mechanism, progress toward IND-enabling activities for AKTX-101 including announced IND-enabling initiatives, intellectual property filings related to PH1’s immuno-oncology mechanism and product combination strategies, leadership updates, and multiple financing activities.
AKTX-101 IND-Enabling Plan and Activities
Our near-term operational strategy remains focused on advancing AKTX-101 into IND-enabling activities and clinical readiness while maintaining the ability to expand our PH1-based ADC pipeline as capital and priorities permit. AKTX-101 is a preclinical Trop2–targeting ADC that combines PH1 with a proprietary non-cleavable linker and antibody construct. We are prioritizing the program’s path to Phase 1 clinical trials through the coordinated execution of GMP product supply and non-clinical data package workstreams that support IND/Phase 1enabling activities.
We rely on third-party CDMOs for development, scale-up, and GMP production of materials used in our research and development activities. In December 2025, we announced the initiation of GMP manufacturing activities for AKTX-101 and selected WuXi Biologics/XDC as our partner for this GMP product supply and related IND-enabling work. This milestone supports our timeline for our Phase 1 first-in-human study described in our public communications while we maintain an efficient, high-quality, and reliable virtual manufacturing model for clinical-grade supply. In December 2025 we publicly described that based on our anticipated for GMP product supply and IND-enabling activities and planning, we are projected to advance AKTX-101 into clinical trials by the first quarter of 2027.
Scientific Disclosures – 2025 SITC Annual Meeting
On November 10, 2025, we issued a press release announcing our abstract highlighting the novel immune mechanism-of-action data for our novel ADC payload, which was presented at the 2025 Society for Immunotherapy of Cancer Annual Meeting. The presentation outlines our investigation of multiple mechanisms behind preclinical colon tumor regressions induced by a Trastuzumab-PH1 ADC as a single agent or in combination with an anti-PD-1 therapy. The results observed with both the single agent Trastuzumab-PH1 ADC and the combination therapy with an anti-PD-1 agent support the possibility of creating an ADC/checkpoint inhibitor therapy paradigm that goes beyond regimens using ADCs with traditional payloads.
Intellectual Property – Expanding Protection Around PH1, Immune Activation, and Combination Strategies
We believe patents and other proprietary rights are an essential element of our business. Our success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, technology, and know-how, to operate without infringing the proprietary rights of others, and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions, and improvements that are important to the development of our business, and defending our patent applications and patents if they are subjected to challenge by third parties.
As of January 1, 2026, our payload platform and ADC pipeline consisted of two Patent Cooperation Treaty (“PCT”) families and three provisional patents filed at the European Patent Office and/or the United States Patent and Trademark Office. The PH1 payload program was developed inhouse, and this patent family has been granted in the United States, China, Israel, India, Mexico, and Brazil, with actions pending in Europe, Japan, New Zealand, Canada and Australia. The composition of matter claims describing novel Thailanstatin payloads and linkers have IP coverage through September 2038.
A PCT patent application filed in 2024 includes claims describing next-generation Thailanstatin diastereomer payloads, novel Trop-2 antibodies and Trop-2 ADCs protecting different aspects of pipeline candidate AKTX-101, while also covering aspects of use or application of AKTX-101 to different cancer settings. This patent also describes a large-scale chemosynthetic process for payload synthesis amenable to manufacturing. This patent family is pending in 12 jurisdictions, and the anticipated expiry of this patent family is April 2043.
In 2025, we filed three additional provisional patent applications at the USPTO intended to broaden our protection around PH1’s mechanism and potential clinical positioning. These provisional filings include claims supporting: (i) targeting of specific oncogenic drivers using spliceosome modulators to reverse aspects of cancer progression, including angiogenesis, hormone dependency, and oncogene dependency; (ii) use of spliceosome modulators as immunogenic payloads inducing neoepitopes and related immune effects, covering elements of the immunomodulatory mechanism of PH1 ADCs and the expected therapeutic benefit through host immune activation; and (iii) use of spliceosome modulators in synergy with checkpoint inhibitors to improve anti-tumor efficacy or induce immune effectors neither single agent can achieve on its own.
Separately, in October 2025, we announced the filing of two new U.S. provisional patent applications. As described publicly, one filing includes claims protecting PH1 and its spliceosome modulatory mechanism of action with an expected therapeutic benefit through immune activation, and a second filing includes claims covering combination therapy of PH1 pipeline ADCs with immuno-oncology drugs, including combinations showing synergy with immune checkpoint inhibitors in preclinical models
Leadership Updates
Appointment of New President and Chief Executive Officer
Appointment
of New President and Chief Executive Officer. On March 14, 2025, we entered into an Executive Offer of Employment Agreement (as amended
by a subsequent Chief Executive Officer Letter Agreement,Agreement dated March 18, 2025) with Mr. Abizer Gaslightwala pursuant to which Mr. Gaslightwala
began will serveserving as our President and Chief Executive Officer,Officer effective on or aroundin April 21, 2025. Mr. Gaslightwala will earn a base salary, which includes an annual cash bonus target, and receive share-based payment compensation based on time service and the achievement of specific performance criteria.
Appointment of Interim Chief Financial Officer. On October 22, 2025, we entered into a consulting agreement with Mr. Kameel Farag and KDF Ventures LLC, as amended on October 31, 2025 (the “Consulting Agreement”), pursuant to which Mr. Farag will serve as our Interim Chief Financial Officer, effective on October 22, 2025. Mr. Farag succeeds our prior Chief Financial Officer, Torsten Hombeck, whose departure was previously reported. The Consulting Agreement provides for monthly cash fees and RSU awards, and provides for a term end date of February 16, 2026, extendable on a month-to-month basis at the Company’s discretion.
Financing and Liquidity Initiatives
We completed multiple financing and liquidity initiatives during 2025 and into early 2026. The summaries below provide high level context only; for additional detail see “Financial Condition, Liquidity and Capital Resources” below.
ADS Ratio Change
On March 17, 2026, we announced the 2026 ADS Ratio Change, which will change the ratio of our ADSs to ordinary shares to a new ratio of one ADS representing 80,000 ordinary shares. The 2026 ADS Ratio Change is expected to be effective on or after March 31, 2026.
On March 2, 2025, we entered into the March 2025 Purchase Agreement, pursuant to which we agreed to sell and issue in a private placement (the “March 2025 Offering”) the Shares as described above, or prefunded warrants in lieu thereof (“Pre-Funded Warrants”), and, in each case, Series A Warrants and Series B Warrants, together with the Pre-Funded Warrants and Series A Warrants, the “Warrants,” and together with the ADSs or Pre-Funded Warrants, the “Units”)). The Units consist of (i) for investors committing less than $1.0 million in the March 2025 Offering (“Tier 1 Investors”) one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase one ADS and a Series B Warrant to purchase one ADS, (ii) for investors committing at least $1.0 million but less than $3.0 million in the March 2025 Offering (“Tier 2 Investors”) one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase 1.25 ADSs and a Series B Warrant to purchase one ADS, and (iii) for investors committing $3.0 million or more in the March 2025 Offering (“Tier 3 Investors”), one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase 1.5 ADSs and a Series B Warrant to purchase one ADS. The purchase price per Unit for investors purchasing ADSs is equal to $0.87 plus (a) $0.25 for Tier 1 Investors, (b) $0.28125 for Tier 2 Investors, or (c) $0.3125 for Tier 3 Investors (the “ADS Unit Purchase Price”). The purchase price per Pre-Funded Warrant and accompanying Series A Warrant and Series B Warrant is equal to $0.67 (which represents the ADS purchase price minus the $0.20 exercise price for such Pre-Funded Warrant) plus (a) $0.25 for Tier 1 Investors, (b) $0.28125 for Tier 2 Investors, or (c) $0.3125 for Tier 3 Investors (the “Pre-Funded Unit Purchase Price”).
As part of the March 2025 Offering, Dr. Huh agreed to purchase $1 million of Units, with the purchase price thereof to be satisfied through his agreement to cancel and extinguish $1.0 million of notes previously issued to him by the Company (the “Note Termination”) for an equal amount of ordinary shares and warrants.
The net proceeds from the March 2025 Offering, after deducting placement agent fees and other offering expenses payable by us, through the filing of this Form 10-K were approximately $3.3 million. We expect to receive the remaining cash proceeds of $3.0 million in April 2025.
The placement agent was paid three percent (3%) of the total number of ADSs issued in the March 2025 Offering, including any of the ADSs issuable upon exercise of the Pre-Funded Warrants (excluding the ADSs issued to Dr. Huh in respect to the Note Termination).
Pipeline Prioritization of the Merged Companies
In May 2024, we announced the completion of a joint portfolio prioritization review pursuant to which the anticipated combined entity, following completion of the proposed Merger (as defined below), will focus on Peak Bio’s ADC platform technology. As a result, our nomacopan program in HSCT-TMA was suspended, with enrollment in our pediatric clinical study discontinued due to cost and timeline. Our PAS-nomacopan GA program has also been suspended and we are looking for an external licensing partner. Following the closing of the Merger on November 14, 2024, we expanded our pipeline of assets spanning early and late development stages with the addition of Peak Bio’s ADC technology platform with novel payload and linker technologies, as well as the Peak Bio PHP-303 small molecule selective and reversible neutrophil elastase inhibitor. The ADC program includes a novel pre-clinical ADC candidate AKTX-101 targeting TROP-2. By combining our ADC program with immunotherapy strategies, we aim to develop cutting-edge solutions for cancer patients. Further, related to PHP-303, we expect to emphasize partnering/collaboration and licensing opportunities with broad potential impact on patients. We also plan to work closely with the FDA to define the best path for this platform and will pursue opportunities for external partnering/collaboration and licensing for nomacopan, including as a potential treatment for pediatric HSCT-TMA.
Restructuring and Reduction-in-Force
In May 2024, we implemented a reduction-in-force (the “RIF”) of approximately 67% of our total workforce, as a result of the recently announced program prioritization under which our nomacopan HSCT-TMA program was suspended. The RIF is part of an operational restructuring plan and includes the elimination of certain senior management positions and was completed by the end of the second quarter of 2024. The purpose of the restructuring plan, including the RIF, was to reduce HSCT-TMA related operating costs, while supporting the execution of our long-term strategic plan. For additional information, refer below to our “Results of Operations” discussion under the heading “Restructuring and Other Costs” and to Note 2 of our consolidated financial statements included in this Form 10-K.
Merger Agreement
On November 14, 2024, we completed the previously announced business combination contemplated by the Agreement and Plan of Merger (the “Merger Agreement”) by and among us, Peak Bio and Pegasus Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Akari (the “Merger Sub”), as amended by a side letter dated August 15, 2024, pursuant to which, upon the terms and subject to the conditions thereof, Merger Sub was merged with and into Peak Bio, with Peak Bio surviving such merger as our wholly owned subsidiary.
For additional information on our acquisition of Peak Bio, please refer to Note 3 of our consolidated financial statements included in this Form 10-K.
During
the year ended December 31, 2024,2025, our loss from operations totaledtotalled $21.6$17.3 million, a 29%20% increase,decrease, compared to a loss from operations
of $16.8$21.6 million for the year ended December 31, 2023.2024. The decrease in our loss from operations from the prior year was primarily
attributable to the merger-related expenses and restructuring and other expenses we incurred in connection with the Merger in 2024
as discussed in further detail below. General and administrative expenses, merger related costsexpenses and restructuringan costsimpairment
loss comprise the majority of our total operating expenses,expenses for the year ended December 31, 2025, as shown in the table below:
During
the year ended December 31, 2024,2025, total research and development expenses increaseddecreased by approximately $1.5$4.2 million, or 28%,60%, compared to
the year ended December 31, 2023.2024. The following sets forth research and development expenses for the years ended December 31, 20242025 and 2023
2024 by category:
ADC discovery and pre-clinical development
These expenses include external expenses that we incurred in connection with the discovery and pre-clinical development of our ADC platform and program(s) and primarily consist of payments to external vendors and consultants. In December 2024, we announced our strategic prioritization of our ADC technology and programs and expect to incur material additional costs going forward related to this program as we plan to invest in additional ADC related discovery and pre-clinical development activities.
These
expenses include external expenses that we have incurred in connection with the development of nomacopan for the treatment of pediatric
HSCT-TMA and primarily consist of payments to CROs and other vendors. TheLess 5%than increase$0.1 million in expenses incurred during the year ended
December 31, 2024,2025, as compared to the year ended December 31, 2023,2024, wereis primarily due to clinicalour trial close-out costs. In May 2024, following the completion of a pipeline prioritization review, we decideddecision to suspend our HSCT-TMA program. Accordingly, we expect future HSCT-TMA costs to decrease following completion of the wind-downAK901
clinical program and close-outfind ofa thecollaborative clinicalpartner trial.for our nomacopan program in 2024.
Bullous Pemphigoid (“BP”) clinical development (AK802)
These expenses previously included external expenses that we incurred in connection with the development of nomacopan for the treatment of BP and primarily consisted of payments to CROs and other vendors. In 2022, we discontinued our BP clinical program and in connection with the final reconciliation of clinical trial close-out costs, we recorded a $1.1 million credit during the year ended December 31, 2023. We do not expect to incur material additional costs related to this program.
ADC preclinical development
These expenses include external expenses that we incurred in connection with the research and discovery of our ADC platform and program(s), and primarily consist of payments to CROs and other vendors. In 2024, we announced our strategic prioritization of our ADC technology and programs and expect to incur material additional costs related to this program as we will invest in additional ADC related preclinical research and discovery activities.
These
expenses include external expenses incurred related to the development and manufacturing of nomacopan for use in clinical trials and
preclinical development of PAS-nomacopan. In general, such expenses primarily consist of payments to contract manufacturing organizations
and other vendors for manufacturing of drug substance (including raw materials), drug product, supplies, and validation, quality assurance
and other manufacturing development activities. The $0.8$3.3 million,million or 30%, increasedecrease in expenses incurred during the year ended December 31, 2024, 2025,
as compared to the year ended December 31, 2023,2024, is primarily due our decision to suspend the timingAK901 ofclinical manufacturingprogram and developmentpre-clinical
PAS-nomacopan activities, including increased spending on the development ofprogram and preparationinstead seek an external partner for manufacturingfurther of PAS-nomacopan.development.
These
expenses include external expenses, such as payments to contract vendors, that may be related to preclinical development activities,
discontinued programs and unallocated expenses. The $0.7 million, or 44%,81%, decrease in expenses incurred during the year ended
December 31, 2024,2025, as compared to the year ended December 31, 2023,2024, is primarily related to lowercessation of costs incurred related to
preclinical studies and other development work investigating PAS-nomacopan for the treatment of GA.
These
expenses include compensation and related costs associated with employees, independent consultants and staffing firms. The $1.1 million, or 36%,$0.4
million decrease in expenses incurred during the year ended December 31, 2024,2025, as compared to the year ended December 31, 2023,2024, is
primarily due to thea impactreduction ofin theworkforce RIF which was announcedinitiated in May 2024,2024 (discussed in further detail below) along with lower costs incurred
for consultants. Separation benefits paid to impacted employees are classified separately under “Restructuring and other expenses”, as discussed below.
The
extent of our future research and development expenditures will be determined based on future funding,funding and following the outcomelocation of anwork assessment of our combined pipeline post-Merger, including program prioritization.performed.
Total general and administrative costs during the year ended December 31, 2025 was $9.3 million, of which $2.5 million was non-cash stock-based compensation, whereas during the year ended December 31, 2024, general and administrative costs was $9.7 million, of which $1.4 million was non-cash stock-based compensation.
DuringThe
$0.4 million decrease in expenses incurred during the year ended December 31, 2024, total general and administrative costs decreased by approximately $1.7 million, or 15%,2025, as compared to the year ended December 31, 2023. The decrease 2024,
was primarily due to decreases in (i) personnel and consulting costs of approximately $1.0$1.1 million resulting from the impactreorganization of the RIF which was announced in May 2024 (excluding separation benefits paid to impacted employees classified separately under “Restructuring
team and other expenses” below),resources, (ii) director and officer insurance premiums of approximately $0.3$0.7 million, and (iii) consulting and professional feesrent of approximately $1.2 $0.2
million. These decreases were partially offset by increases in otherstock-based expensescompensation of approximately $0.8$1.1 million related toand regulatory and legal fees.fees of approximately
$0.5 million.
Impairment loss
During the year ended December 31, 2025, we recognized an impairment loss on the in-process R&D related to PHP 303 which was acquired in connection with the Merger. The impairment loss was triggered due to reprioritization of resources to our ADC platform, no further development plans and inability to find a collaborative partner to date.
What changed in the latest 10-Q
Risk Factors
Full comparison: every changed paragraph (1)
As
of MarchJune 31,30, 2026,
we had in-process research and development (“IPR&D”) of approximately $30.3 million, primarily relating
to AKTX-101 and
our ADC Platform. Our intangible assets have been previously impaired and remain subject to additional impairment analyses
whenever an
event or change in circumstances indicates the carrying amount of such an asset may not be recoverable. Events giving rise
to impairment
are difficult to predict and are an inherent risk in the pharmaceutical industry. Some of the potential risks that could
result in further
impairment of our IPR&D include negative preclinical or clinical trial results, adverse regulatory developments,
delay or failure
to obtain regulatory approval, additional development costs, changes in the manner of our use or development of our
product candidates,
competition, earlier than expected loss of exclusivity, pricing pressures, higher operating costs, our inability
to identify or enter
into strategic partnerships, collaborations or out-licensing arrangements on acceptable terms or at all, geopolitical
conflicts, changes
in tax laws, prices that third parties are willing to pay for our IPR&D or similar assets in an arm’s length
transaction being
less than the carrying value of our IPR&D, declines in our market capitalization, and other adverse market and
economic environment
changes or trends. Any and all of these conditions are reasonably likely to exist in the future and materialization
of these risks or
other changes in circumstances may lead to significant impairment charges on our IPR&D in the future, which could
materially materially
adversely affect our financial results.
Management's Discussion & Analysis (MD&A)
New heading “Strategic Research Collaboration with Whitehawk Therapeutics”
New heading “Publication American Association for Cancer Research (AACR) Cancer Research Journal”
New heading “Intellectual Property – Expanding Protection Around AKTX 101”
New heading “May 2026 Financing”
New heading “Benefit from deferred income taxes”
New heading “May 2026 Financing”
Removed heading “ADS Ratio Change”
Largest changes
“Strategic Research Collaboration with Whitehawk Therapeutics”see in full comparison
“Publication American Association for Cancer Research (AACR) Cancer Research Journal”see in full comparison
“We closed a private placement (“May 2026 Private Placement”) with certain investors in two tranches on May 27, 2026 and June 26, 2026 providing for the issuance and sale of an aggregate of 1,470,588 ADSs, (or prefunded warrants to purchase ADSs in lieu thereof), each representing 80,000 of the Company’s ordinary shares, and, accompanying each ADS (or prefunded warrant in lieu thereof), one Series H warrants to purchase one ADS, one Series I warrants to purchase one ADS and one Series J warrants to purchase one ADS. …”see in full comparison
Full comparison: every changed paragraph (45)
Strategic Research Collaboration with Whitehawk Therapeutics
On July 21, 2026, we announced a strategic research collaboration with Whitehawk Therapeutics, a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently develop improved ADC cancer treatments. Under the collaboration, we will conduct a series of focused preclinical studies evaluating Akari’s proprietary PH1 spliceosome-modulating payload technology in combination with Whitehawk’s topoisomerase I inhibitor ADC platform. We will lead the design, execution and evaluation of the research activities.
Publication American Association for Cancer Research (AACR) Cancer Research Journal
In April 2026, we issued a press release announcing the presentation of positive preclinical data for our lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) Annual Meeting 2026. The preclinical data compares the performance of AKTX-101 versus TROP2 ADCs with Topoisomerase I Inhibitor payloads in the killing of different cancer types driven by different cancer genes (oncogenes). AKTX-101’s ability to kill cancer cells at lower concentrations vs. TROP2 ADCs using Topoisomerase I Inhibitor payloads suggests in our view that AKTX-101 is a more potent drug. The preclinical data was published as an abstract in Cancer Research, an AACR journal.
AKTX-101 demonstrated greater potency and/or greater maximum cancer cell killing relative to TROP2 ADC Topoisomerase I Inhibitor payloads in cancers of the bladder, lung and breast. AKTX-101 demonstrated sub-nanomolar potency in all bladder cancer lines tested, a key tumor in which first-in-human clinical trials for AKTX-101 are planned. AKTX-101 also demonstrated sub-nanomolar potency in several non-small cell lung cancer cell lines driven by EGFR, BRAF, and SMARCA4, as well as potent cell killing in HER2 breast cancer cell lines with inherent resistance to Topoisomerase I Inhibitor ADCs such as trastuzumab deruxtecan (ENHERTU™). We believe that these findings show that AKTX-101 has strong potential for targeting a broad range of cancer tumors and sub-types with superior cytotoxicity than current TROP2 ADCs that use Topoisomerase I Inhibitor payloads.
On
April 21, 2026, we issued a press release announcing ourbreakthrough abstractpreclinical titleddata Combinationdemonstrating synergysynergistic activity of spliceosome modulator ADCAKTX-101 with
KRAS a K-Ras
inhibitorinhibition in KRAS–mutatedKRAS-mutated pancreatic cancerscancer models, which was acceptedfeatured forin an online publication at the American Society of Clinical
Oncology Oncology
(ASCO) Annual Meeting 2026. This provides continued validation of our novel RNA splicing modulator payload platform for ADCs,
and its
broad potential in treating a wide range of cancer tumors, including those with KRAS mutations, a rapidly expanding therapeutic
category. category.
We believe this data highlights a growing body of evidence demonstrating that targeting RNA splicing in cancer cells could
be a powerful
way to attack even the most difficult cancers.
Intellectual Property – Expanding Protection Around AKTX 101
We believe patents and other proprietary rights are an essential element of our business. Our success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, technology, and know-how, to operate without infringing the proprietary rights of others, and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions, and improvements that are important to the development of our business, and defending our patent applications and patents if they are subjected to challenge by third parties.
During the six months ended June 30, 2026, we received Australian patent protection covering the PH1 RNA splicing modulator ADC payload, and a European patent that provides composition of matter protection for our Thailanstatin-based payloads.
May 2026 Financing
We closed a private placement (“May 2026 Private Placement”) with certain investors in two tranches on May 27, 2026 and June 26, 2026 providing for the issuance and sale of an aggregate of 1,470,588 ADSs, (or prefunded warrants to purchase ADSs in lieu thereof), each representing 80,000 of the Company’s ordinary shares, and, accompanying each ADS (or prefunded warrant in lieu thereof), one Series H warrants to purchase one ADS, one Series I warrants to purchase one ADS and one Series J warrants to purchase one ADS. The purchase price per ADS and accompanying series warrants was equal to $3.74 and the purchase price per prefunded warrant and accompanying series warrants was equal to $3.739. For more information, please refer to “Financial Condition, Liquidity and Capital Resources – May 2026 Private Placement” below.
ADS
Ratio Change
On
March 31, 2026, we completed our previously announced 2026 ADS Ratio Change, which changed the ratio of our ADSs to ordinary shares to
a new ratio of one ADS representing 80,000 ordinary shares.
Three
and Six Months Ended MarchJune 31,30, 2026 and 2025
During
the three months ended MarchJune 31,30, 2026, our loss from operations increasedtotaled by $12.2$4.6 million, as compared to a loss from operations of $3.1 million
for the three months ended June 30, 2025, which was primarily driven by increase in research and development activities. During the six
Marchmonths 31,ended June 30, 2026, our loss from operations totaled $20.4 million, as compared to a loss from operations of $6.6 million for
the six months ended June 30, 2025, which was primarily due to a $12.1 million non-cash impairment on other intangible assets and goodwill.
Our total operating
expenses are set forth by category in the table below:
During
the three months ended MarchJune 31,30, 2026, total research and development expenses increased by approximately $0.6$1.4 million, as compared to
the three months ended MarchJune 31,30, 2025. During the six months ended June 30, 2026, total research and development expenses increased by
approximately $2.1 million, as compared to the six months ended June 30, 2025. The following sets forth research and development expenses
for the three and six months ended MarchJune 31,
30, 2026 and 2025 by category:
These
expenses include external expenses to contract vendors that may be related to pre-clinical development activities, discontinued
programs programs
and unallocated expenses. The decrease of $0.2 millionincrease in expenses of less than $0.1 million incurred during the three months ended March 31,June
30, 2026, as compared
to the three months ended MarchJune 31,30, 2025, was due to a recovery of expenses related to a trial for a nomacopan
program. The decrease in expenses of $0.1 million incurred during the six months ended June 30, 2026, as compared to the six months
ended June 30, 2025 is primarily related to lower costs incurred related to our HSCT-TMA, PAS-nomacopan, and PHP-303
program. programs. In December
2024, we announced our decision to suspend these programs and find a collaborative partner.
These
expenses include compensation and related costs associated with employees. The decrease in expenses of $0.4 million decreaseand $0.8 million,
incurred during the three and six months ended March
31,June 30, 2026, as compared to the three and six months ended March 31, 2025, respectively,
is primarily due to decreases in non-cash stock-based compensation expense
and lower cash-based salaries.
During
the three months ended MarchJune 31,30, 2026, total general and administrative costs decreasedincreased by approximatelyless $0.5than $0.1 million as compared to
the three
months ended MarchJune 31,30, 2025, primarily due to decreasesan increase in non-cash stock-based compensation expense.
During the six months ended June 30, 2026, total general and administrative costs decreased by approximately $0.5 million as compared to the six months ended June 30, 2025, primarily due to a decrease in non-cash stock-based compensation expense of $0.4 million and a decrease in personnel and professional fees of $0.1 million.
During
the threesix months ended MarchJune 31,30, 2026, we recognized non-cash impairment losses on goodwill, and in process research and development
(“IPR&D”)
assets recorded in connection with our December 2024 merger with Peak Bio, Inc. The impairment assessment was
triggered by the sustained
decline in the Company’s market capitalization as of March 31, 2026, which required a reassessment of
the carrying value of these
assets.
No such impairment loss was recognized in the three months ended June 30, 2026 or the three and six months ended June 30, 2025.
During
the threesix months ended MarchJune 31,30, 2026, we recognized a gain on settlement of current liabilities of approximately $0.2 million which relates
relates to settlements with former vendors for outstanding payables. During the three and six months ended MarchJune 31,30, 2025, we recognized a gain
on settlement of current liabilities of less than $0.1$1.2 million which related to an extinguishment ofwith a $0.4former millionvendor promissoryfor noteoutstanding assumedpayables. No settlements were recognized in
by the Companythree onmonths Novemberended 14,June 2024,30, in connection with our acquisition of Peak Bio.2026.
Change
in fair value of warrant liabilities represents non-cash warrant revaluation gains or losses related to the re-measurement of our liability-classified
instruments, namely our September 2022 Warrants and the warrants we assumed on November 14, 2024, in connection with ourthe acquisition
ofMerger Peak BioClosing (the “Peak Bio Warrants”). Due to the nature of and inputs in the model used to assess the fair value of our
outstanding September 2022 Warrants and Peak Bio Warrants, it is not unusual to experience significant fluctuations during each re-measurement
period. These fluctuations may be due to a variety of factors, including changes in our stock price and changes in estimated stock price
volatility over the remaining life of the warrants.
During the three and six months ended June 30, 2026, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation loss of $0.1 million each, which was primarily driven by an increase in our stock price and estimated stock price volatility. During the three and six months ended June 30, 2025, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation gain of $0.1 million each, which was driven by a decrease in our stock price.
During
the three months ended March 31, 2026, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation
gain of less than $0.1 million, which was primarily driven by a decrease in our stock price. During the three months ended March 31,
2025, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation loss of less than $0.1 million,
which was driven by an increase in our stock price.
During
the threesix months ended MarchJune 31,30, 2026, we recognized a non-cash revaluation gain of $0.2 million in relation to the embedded derivative
derivative in the White Lion ELOC, which was primarily attributable to the effect of the ADS Ratio Change. No such loss was
recognized during the
three months ended MarchJune 31,30, 2026 and the three and six months ended June 30, 2025.
During
the three months ended MarchJune 31,30, 2026 and 2025, we recorded a net foreign currency exchange loss of less than $0.1 million each. During
the six months ended June 30, 2026 and 2025, we recorded a net foreign currency exchange gain of less than $0.1 million each and a foreign
currency exchange loss of approximately $0.1$0.2 million, respectively. Exchange gains and losses can fluctuate significantly from period
to period due to changes in exchange rates, as well as the volume and timing of expenditures and related payments denominated in foreign
currencies.
Benefit from deferred income taxes
During the six months ended June 30, 2026, we recognized a deferred income tax recovery of $0.8 million, in connection with the impairment loss on other intangible assets described above. No such recovery was recognized during the three months ended June 30, 2026 and the three and six months ended June 30, 2025.
As
a result of the factors discussed above, our net loss applicable to ordinarycommon shareholders for the three months ended MarchJune 31,30, 2026,2026 was
$14.5$4.8 million, compared to net loss applicable to ordinary shareholders for the three months ended MarchJune 31,30, 2025 of $3.7$1.9 million. Our
net loss applicable to common shareholders for the six months ended June 30, 2026 was $19.3 million, compared to net loss applicable
to ordinary shareholders for the six months ended June 30, 2025 of $5.6 million.
Since
inception, we have incurred substantial losses, and we have primarily funded our operations with proceeds from the sale of equity securities,
including ordinary shares, warrants and pre-funded warrants, and convertible notes. On MarchJune 31,30, 2026, we had $2.8$7.7 million in cash and
an accumulated deficit of $279.0$283.8 million. To date, we have not generated any revenue.
May 2026 Financing
In May 2026, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company sold and issued in a private placement (the “May 2026 Private Placement”) an aggregate of 1,470,588 unregistered American Depository Shares (“ADSs”), or prefunded warrants to purchase ADSs (“Pre-Funded Warrants”), each ADS representing 80,000 of the Company’s ordinary shares per ADS, together with one Series H warrants, one Series I warrants and one Series J warrants to purchase an equivalent number of ADSs (the Series H, Series I, and Series J warrants collectively referred to as the “Series Warrants”). The purchase price per ADS and accompanying Series Warrants was equal to $3.74 and the purchase price per Pre-Funded Warrant and accompanying Series Warrants was equal to $3.739.
The Series H Warrants, Series I Warrants, and Series J Warrants were issued on June 30, 2026, following requisite shareholder approval and are exercisable at a price of $3.74 per ADS. The Series H Warrants have an eighteen-month term, and the Series I and J warrants have a five-year term. The Pre-Funded Warrants have an exercise price of $0.001 per ADS, became exercisable immediately when issued and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full.
At close of the May 2026 Private Placement, the Company incurred a total of approximately $0.1 million in placement agent fees with Paulson Investment Company, LLC (“Paulson”) and were required to issue 117,647 ADSs.
Net proceeds from the May 2026 Private Placement were approximately $5.2 million.
Concurrently with the ELOC Purchase Agreement, the Company and the Purchaser entered into the White Lion RRA, pursuant to which the Company agreed to file the ELOC Resale Registration Statement. The Company filed the ELOC Resale Registration Statement on August 29, 2025, which was subsequently amended on June 26, 2026, and was declared effective by the SEC on July 7, 2026.
Concurrently
with the ELOC Purchase Agreement, the Company and the Purchaser entered into a Registration Rights Agreement, dated August 29, 2025 (the
“Registration Rights Agreement”), pursuant to which the Company agreed to file a registration statement on Form S-1 (or any
successor form) with the SEC within thirty (30) calendar days following August 29, 2025, to register the resale of the maximum number
of Registrable Securities (including the Ordinary Shares, Commitment Shares, and ADSs representing such shares) permitted by applicable
SEC rules. The Company shall use its commercially reasonable efforts to have the registration statement declared effective as soon as
practicable and to maintain its effectiveness during the Registration Period, which continues until all Registrable Securities are sold,
the ELOC Purchase Agreement terminates and no Registrable Securities are held, or the securities cease to be Registrable Securities under
specified conditions.
As
of MarchJune 31,30, 2026, the Company had no outstanding purchase notices issued to White Lion.
As
of the date of this report, our existing cash is sufficient to fund our operations into JuneDecember 2026. While we have additional funding
activities activities
in progress to fund our operations, we will need to raise additional capital to continue to fund our operations and service
our obligations
in the future. If we are unable to raise additional capital when needed, we will not be able to continue as a going concern.
We do not
currently have any products approved for sale and do not generate any revenue from product sales. We are currently seeking
and expect
to continue to seek additional funding through financings of equity and/or debt securities. We may also engage in strategic
research research
and development collaborations, pre-clinical and clinical funding arrangements, the sale or license of technology assets, and/or
other other
strategic alternatives.
Operating
Activities. The net cash used in operating activities for the periods presented consists primarily of our net loss adjusted for non-cash
non-cash charges and changes in components of working capital. The increase in cash used in operating activities during the three
six months ended March 31,June
30, 2026, as compared to the threesix months ended MarchJune 31,30, 2025, was primarily due to an increase in research and
development costs.
Investment Activities. There were no investing activities during the six months ended June 30, 2026 and 2025.
We
have outstanding convertible notes and promissory notes with third parties, assumed from the acquisition of Peak Bio Inc., as more fully
described in Note 6 to our unaudited condensed consolidated financial statements appearing in this Form 10-Q. As of MarchJune 31,30, 2026, these
obligations are expected to result in principal payments of approximately $0.7 million.
See
“Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting
Accounting Estimates” of our Form 10-K, for a discussion of significant estimates and assumptions made by our management
as part of the
preparation of this management’s discussion and analysis of financial condition and results of operations and
accompanying condensed
consolidated financial statements. There have been no material changes to our critical accounting estimates
since December 31, 2025,
except the estimates related to other intangible assets and goodwill as of MarchJune 31,30, 2026. Refer to Note 3 of our unaudited condensed
consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further details of our impairment assessment of goodwill
goodwill and other intangibles assets asduring ofthe quarter ending March 31, 2026.
AKTX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-29 | Gaslightwala Abizer |
Grant/award | 6,430 | $9.72 | $62.5K |
| 2026-08-17 | Farag Kameel D. |
Grant/award | 1,728 | $7.52 | $13.0K |
| 2026-07-16 | Farag Kameel D. |
Grant/award | 1,130 | $11.50 | $13.0K |
| 2026-07-07 | Patel Samir Rashmikant |
Option exercise | 1,209 | $8.00 | $9.7K |
| 2026-07-07 | Patel Samir Rashmikant |
Option exercise | 15,466 | — | — |
| 2026-07-07 | Patel Samir Rashmikant |
Option exercise | 5,799 | — | — |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 1,570 | $8.28 | $13.0K |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 7,353 | $3.74 | $27.5K |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 1,000 | $13.00 | $13.0K |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 2,539 | $5.12 | $13.0K |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 3,725 | $3.49 | $13.0K |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 1,395 | $9.32 | $13.0K |
| 2026-06-24 | Farag Kameel D. |
Grant/award | 1,248 | $10.02 | $12.5K |
Well-known investors holding AKTX (13F)
None of the 59 investors we track reported a position in their latest 13F.