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Akari Therapeutics Plc

For the period ended Jun 30, 2025. Filed Aug 13, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 13, 2025

AKTX$7.37-4.9%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-14.

0000950170-25-071563

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-06-30; filed 2025-08-13.

0001641172-25-023569

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 136 previous paragraphs and 122 current paragraphs.

62 unchanged; 31 reworded; 28 added; 42 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 3 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (28)

Current report

In August 2025, we entered into Note Purchase Agreements with certain investors and the directors of the Company (the “August 2025 Note Investors”), pursuant to which we agreed to issue unsecured promissory notes with a 20% original issuance discount (each a “August 2025 Note” and together, the “August 2025 Notes”) in a private placement (the “2025 August Notes Offering”) for an aggregate purchase price of $3 million, inclusive of the exchange Note Termination (as defined below). The aggregate principal amount of the August 2025 Notes issuable is $3.8 million. The August 2025 Notes mature one year from the date of issuance at which time the principal amount is due and payable. In connection with the 2025 August Notes Offering, the Company’s Chairman, Dr. Hoyoung Huh, agreed to purchase an August 2025 Note with a principal amount of $1,250,000 for a purchase price of $1,000,000, with the purchase price thereof to be satisfied through his agreement to cancel and extinguish $837,433 of outstanding principal and accrued interest under a senior secured promissory note previously issued to him by Peak Bio in January 2024, which was assumed by the Company (the “Note Termination”) plus cash of $162,567. Further, we agreed to amend the Series A Warrants (as defined below) previously issued in the March 2025 Private Placement to certain of the August 2025 Note Investors, at the closing of the 2025 August Notes Offering to extend expiration date from 2026 to 2030. The 2025 August Notes Offering is expected to close in two tranches in August and September 2025.

Current report

We also agreed to pay a 5% transaction fee in cash of the total gross cash proceeds of $2.2 million to Paulson Investment Company (“Paulson”) in connection with the August 2025 Notes Offering.

Current report

In March 2025, the Company entered into a securities purchase agreement with certain investors and all directors, pursuant to which the Company sold and issued in a private placement (the “March 2025 Private Placement”) ADSs, or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof, each representing 2,000 of the Company’s ordinary shares (the “Shares”), and, in each case, Series A warrants to purchase ADSs (“Series A Warrants”) and Series B warrants to purchase ADSs (“Series B Warrants”), the “Warrants,” and together with the ADSs or Pre-Funded Warrants, the “Units”). The Series A Warrants and Series B Warrants have a one-year term and a five-year term from the date of issuance, respectively, and the number of ADSs issuable pursuant to the exercise of each Series A Warrant ranges from 1 ADS to 1.5 ADSs depending on the “tier” of investment made.

Current report

In April 2025, the Company closed its final round of financing under the March 2025 Private Placement and issued 2,704,595 ADSs, Pre-Funded Warrants to purchase up to 1,650,000 ADS at a price of $0.20 per ADS, Series A Warrants to purchase up to 6,057,405 ADS, at a per unit price of $0.87 per ADS, and Series B Warrants to purchase up to 4,354,595 ADS, at a per unit price of $0.87 per ADS.

Current report

At close of the March 2025 Private Placement, we incurred a total of approximately $0.4 million in placement agent fees with Paulson and issued 172,344 ADSs with an estimated fair value of $0.2 million. Net proceeds from the March 2025 Private Placement were approximately $5.6 million, net of the $1.0 million from the March 2025 Note Termination.

Current report

During the six months ended June 30, 2025, total general and administrative costs increased by approximately $0.3 million, or 5%, as compared to the six months ended June 30, 2024, primarily due to an increase in non-cash stock-based compensation expense of $1 million, an increase of $0.2 million in professional fees (primarily driven from Merger related financial disclosures), partially offset by a decrease of approximately $0.5 million in cash-based salaries, a decrease of approximately $0.4 million in premiums for our directors and officers insurance.

Current report

Merger-related costs consist of direct expenses incurred in connection with the Merger and are comprised primarily of legal and professional fees.

Current report

Merger-related costs for the three and six months ended June 30, 2024 were $0.3 million and $1.3 million, respectively. No such costs were incurred during three and six months ended June 30, 2025.

Current report

Restructuring costs consist primarily of severance and related benefit costs related to workforce reductions incurred in connection with the RIF, which the Company began to implement in May 2024.

Current report

Restructuring and other costs for both of the three and six months ended June 30, 2024 were $1.6 million, including $0.3 million of non-cash share-based compensation expense. No such costs were incurred during three and six months ended June 30, 2025.

Current report

During the three months ended June 30, 2025, we recognized a gain on settlement of current liabilities of $1.2 million with a former vendor.

Current report

During the six months ended June 30, 2025, we recognized a gain on settlement of current liabilities of $1.2 million which is comprised of a gain on settlement of $1.2 million with a former vendor and a less than $0.1 million gain on debt extinguishment related to a promissory note issued by Peak Bio in November 2023 and assumed by the Company in November of 2024 in the amount of $0.4 million, bearing interest at 6% per annum with a maturity date of December 31, 2024 (the “November 2023 Note”).

Current report

In August 2025, the Company entered into Note Purchase Agreements with certain investors and the Company’s directors (the “August 2025 Note Investors”), pursuant to which the Company agreed to issue unsecured promissory notes with a 20% original issuance discount (each a “August 2025 Note” and together, the “August 2025 Notes”) in a private placement (the “August 2025 Notes Offering”) for an aggregate purchase price of $3 million, inclusive of the exchange Note Termination (as defined below). The aggregate principal amount of the August 2025 Notes issuable is $3.8 million. The August 2025 Notes mature one year from the date of issuance at which time the principal amount is due and payable. In connection with the 2025 August Notes Offering, the Company’s Chairman, Dr. Hoyoung Huh, agreed to purchase an August 2025 Note with a principal amount of $1,250,000 for a purchase price of $1,000,000, with the purchase price thereof to be satisfied through his agreement to cancel and extinguish $837,433 of outstanding principal and accrued interest under a senior secured promissory note previously issued to him by Peak Bio in January 2024, which was assumed by the Company (the “Note Termination”) plus cash of $162,567. Further, the Company agreed to amend the Series A Warrants previously issued in the March 2025 Private Placement to certain of the August 2025 Note Investors, at the closing of the 2025 August Notes Offering to extend the expiration date from 2026 to 2030. The 2025 August Notes Offering is expected to close in two tranches in August and September 2025.

Current report

The Company also agreed to pay a 5% advisory fee in cash of the total gross cash proceeds of approximately $2.2 million to Paulson Investment Company (“Paulson”) in connection with the August 2025 Notes Offering.

Current report

In March 2025, the Company entered into a securities purchase agreement (the “March 2025 Private Placement”) with certain investors and all directors, pursuant to which the Company sold and issued in a private placement ADSs, or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof, each representing 2,000 of the Company’s ordinary shares (the “Shares”), and, in each case, Series A warrants to purchase ADSs (“Series A Warrants”) and Series B warrants to purchase ADSs (“Series B Warrants”), the “Warrants,” and together with the ADSs or Pre-Funded Warrants, the “Units”). The Series A Warrants and Series B Warrants have a one-year term and a five-year term from the date of issuance, respectively, and the number of ADSs issuable pursuant to the exercise of each Series A Warrant ranges from 1 ADS to 1.5 ADSs depending on the “tier” of investment made.

Current report

In March 2025, the Company closed its first round of financing under the March 2025 Private Placement and issued 2,238,031 ADSs, Series A Warrants to purchase up to 2,283,031 ADS, at a per unit price of $0.87 per ADS, and Series B Warrants to purchase up to 2,283,031 ADS, at a per unit price of $0.87 per ADS. In connection with this round of financing, the Company’s Chairman, Dr. Hoyoung Huh, agreed to purchase $1.0 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 Peak Bio in January 2024, which were assumed by the Company (the “March 2025 Note Termination”) for an equal amount of ordinary shares and warrants.

Current report

In April 2025, the Company closed its final round of financing under the March 2025 Private Placement and issued 2,704,595 ADSs, Pre-Funded Warrants to purchase up to 1,650,000 ADS at a price of $0.20 per ADS, Series A Warrants to purchase up to 6,057,405 ADS, at a per unit price of $0.87 per ADS, and Series B Warrants to purchase up to 4,354,595 ADS, at a per unit price of $0.87 per ADS. The Company received approximately $0.3 million in advance for the Pre-funded Warrants which is reflected in other current liabilities.

Current report

At close of the March 2025 Private Placement, we incurred a total of approximately $0.4 million in placement agent fees with Paulson and issued 172,344 ADSs with an estimated fair value of $0.2 million. Net proceeds from the March 2025 Private Placement were approximately $5.6 million, net of the $1.0 million from the March 2025 Note Termination.
Removed paragraphs (42)

Previous report

our unaudited condensed consolidated financial statements and accompanying notes included in Part I, Item 1 of this Form 10-Q; and

Previous report

our audited consolidated financial statements and accompanying notes included in our Form 10-K, as well as the information contained under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K.

Previous report

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;

Previous report

ability to be used in combination with checkpoint inhibitors to potentially deliver synergistic efficacy results (more than additive);

Previous report

sustained duration of response of tumor regression or elimination;

Previous report

improved safety and tolerability relative to ADCs that are currently available.

Previous report

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”) an aggregate of 6,637,626 ADSs, 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”).

Previous report

The net proceeds from the March 2025 Offering, after deducting placement agent fees and other offering expenses payable by us, were approximately $6.0 million, of which $4.0 million was received in April 2025.

Previous report

In addition to a cash commission, the placement agent was also 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).

Previous report

the progress and costs of our preclinical studies, clinical trials and other research and development activities;

Previous report

the costs associated with the integration activities related to the Merger;

Previous report

the scope, prioritization and number of our clinical trials and other research and development programs;

Previous report

the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to our product candidates;

Previous report

the costs of the development and expansion of our operational infrastructure;

Previous report

the costs and timing of obtaining regulatory approval for our product candidates;

Previous report

the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

Previous report

the costs and timing of securing manufacturing arrangements for clinical or commercial production;

Previous report

the costs of contracting with third parties to provide sales and marketing capabilities for us;

Previous report

the magnitude of our general and administrative expenses; and

Previous report

any cost that we may incur under future in- and out-licensing arrangements relating to current or future product candidates.

Previous report

In March 2025, we entered into the March 2025 Purchase Agreement with certain investors, including all of our directors, pursuant to which we agreed to sell and issue in a private placement an aggregate of a combination of Units. For more information, see “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Recent Developments—March 2025 Private Placement.”

Previous report

significantly delay, scale back, or discontinue the development or commercialization of our product candidates;

Previous report

seek strategic alliances for research and development programs at an earlier stage than otherwise would be desirable or that we otherwise would have sought to develop independently, or on terms that are less favorable than might otherwise be available in the future;

Previous report

dispose of technology assets, including current product candidates, or relinquish or license on unfavorable terms, our rights to technologies or any of our product candidates that we otherwise would seek to develop or commercialize ourselves;

Previous report

pursue the sale of our company to a third party at a price that may result in a loss on investment for our shareholders; or

Previous report

the receptivity of the capital markets to financings by biotechnology companies generally and companies with drug candidates and technologies similar to ours specifically;

Previous report

the receptivity of the capital markets to any in-licensing, product acquisition or other transaction we may enter into or attempt to enter into;

Previous report

our ability to successfully integrate operations with Peak Bio following the Merger and realize

Previous report

the results of our preclinical and clinical development activities in our drug candidates we develop on the timelines anticipated;

Previous report

competitive and potentially competitive products and technologies and investors’ receptivity to our drug candidates we develop and the technology underlying them in light of competitive products and technologies; and

Previous report

For the three months ended March 31, 2025, an aggregate of $1.2 million in net proceeds received from the March 2025 Private Placement, an aggregate of $1.1 million received from advance deposits related to the second closing of the March 2025 Private Placement that occurred subsequent to March 31, 2025, partially offset by $0.5 million of payments related to our promissory notes and $0.1 million of payments for our insurance premium financing; and

Previous report

For the three months ended March 31, 2024, an aggregate of $1.7 million in net proceeds received from the March 2024 Private Placement, partially offset by $0.2 million of payments for our insurance premium financing.

Showing the first 40 of 42 passages. Open the source sections for the rest.

Reworded paragraphs (31)

Previous wording

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, 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.

Current wording

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, CD19, CD22, CD30, Nectin-4, Tissue Factor, and FR alpha antibodies. However, there is a lack of diversity in the payload toxins to which those antibodies are conjugated to, as more than 90% of ADCs approved or 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.

Previous wording

Our lead product candidate is AKTX-101, a preclinical stage Trop2-targeting ADC that combines PH1 with the Trop2 antibody, which is expressed in the highest number of solid tumor cancer types, including lung, breast, colon and prostate. We aim to establish AKTX-101 as a best-in-class Trop2-targeting ADC for the treatment of a variety of solid tumors.

Current wording

Our lead product candidate is AKTX-101, a pre-clinical stage Trop2-targeting ADC that combines our novel payload PH1, a spliceosome modulator with the Trop2 antibody. Trop2 is an antigen, which is expressed differentially at higher levels in a number of solid tumor cancer types, including lung, breast, colon and urothelial, and gastric. We aim to establish AKTX-101 as a potential best-in-class Trop2-targeting ADC for the treatment of a variety of solid tumors.

Previous wording

We acquired the ADC Platform in connection with the acquisition of Peak Bio (the “Merger”). Prior to that time, we were primarily focused on advancing our former lead 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. For our PHP-303 program, a program that Peak Bio had advanced prior to the closing of the Merger, we intend to seek strategic partners for it as well to further its development externally.

Current wording

We acquired the ADC Platform in connection with our acquisition of Peak Bio (the “Merger”). Prior to that time, we were primarily focused on advancing our former lead 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 discovery and pre-clinical 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. For our PHP-303 program, a program that Peak Bio had advanced prior to the closing of the Merger, we also intend to seek strategic partners to further its development externally.

Previous wording

On March 14, 2025, we entered into an Executive Offer of Employment Agreement (as amended by a subsequent Chief Executive Officer Letter Agreement, dated March 18, 2025) with Mr. Abizer Gaslightwala pursuant to which Mr. Gaslightwala will serve as our President and Chief Executive Officer, effective on 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.

Current wording

On March 14, 2025, we entered into an Executive Offer of Employment Agreement (as amended by a subsequent Chief Executive Officer Letter Agreement, dated March 18, 2025) with Mr. Abizer Gaslightwala pursuant to which Mr. Gaslightwala will serve as our President and Chief Executive Officer, effective on April 21, 2025. As compensation, Mr. Gaslightwala is paid a base salary, which includes an annual cash bonus target, and is entitled to receive share-based payment compensation based on time service and the achievement of specific performance criteria.

Previous wording

As part of the March 2025 Offering, Dr. Hoyoung Huh, our Chairman of the Board, 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.

Current wording

In March 2025, the Company closed its first round of financing under the March 2025 Private Placement and issued 2,238,031 ADSs, Series A Warrants to purchase up to 2,283,031 ADS, at a per unit price of $0.87 per ADS, and Series B Warrants to purchase up to 2,283,031 ADS, at a per unit price of $0.87 per ADS. In connection with this round of financing, the Company’s Chairman, Dr. Hoyoung Huh, agreed to purchase $1.0 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 Peak Bio in January 2024, which were assumed by the Company (the “March 2025 Note Termination”) for an equal amount of ordinary shares and warrants.

Previous wording

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 clinical stage nomacopan program in HSCT-TMA was suspended, with enrollment in our pediatric clinical study discontinued due to cost and timeline. Our preclinical PAS-nomacopan program in Geographic Atrophy (“GA”) has also been suspended from further internal development and we are looking for an external licensing partner to continue its further development. Following the closing of the Merger on November 14, 2024, we expanded our pipeline of assets from Peak Bio spanning preclinical to clinical stage development with the addition of Peak Bio’s proprietary 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 potentially combining our ADC program with other immunotherapy strategies, we aim to develop cutting-edge solutions for cancer patients. Further, related to our PHP-303 program, we expect to emphasize partnering/collaboration and licensing opportunities with broad potential impact on patients.

Current wording

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 clinical stage nomacopan program in hematopoietic stem cell transplantation-associated thrombotic microangiopathy (“HSCT-TMA”) was suspended, with enrollment in our pediatric clinical study discontinued due to cost and timeline. Our pre-clinical PAS-nomacopan program in Geographic Atrophy (“GA”) has also been suspended from further internal development and we are looking for an external licensing partner to continue its further development. Following the closing of the Merger on November 14, 2024, we expanded our pipeline of assets from Peak Bio with the addition of Peak Bio’s proprietary 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 with Akari’s novel payload, PH1. Akari aims to develop several ADC candidates utilizing its novel PH1 payload, a spliceosome modulator, to significantly improve the outcomes for cancer patients across a range of tumors. Further, related to our PHP-303 program, we do not invest any resources to advance this program internally and instead expect to emphasize partnering/collaboration and licensing opportunities with broad potential impact on patients.

Previous wording

During the three months ended March 31, 2025, our loss from operations totaled $3.5 million, a 41% decrease, compared to a loss from operations of $6.0 million for the three months ended March 31, 2024. General and administrative expenses comprise the majority of our total operating expenses, as shown in the table below:

Current wording

During the three months ended June 30, 2025, our loss from operations totaled $3.1 million, a 58% decrease, compared to a loss from operations of $7.4 million for the three months ended June 30, 2024. During the six months ended June 30, 2025, our loss from operations totaled $6.6 million, a 51% decrease, compared to a loss from operations of $13.4 million for the six months ended June 30, 2024. Our total operating expenses are set forth by category in the table below:

Previous wording

Our research and development expenses are charged to operations as incurred and we incur both direct and indirect expenses for each of our programs. We track direct research and development expenses by preclinical and clinical programs, which may include third-party costs such as CROs, contract laboratories, consulting, and clinical trial costs. We do not allocate indirect research and development expenses, which may include product development and manufacturing, clinical, medical, regulatory, laboratory (equipment and supplies), personnel, facility and other overhead costs, to specific programs.

Current wording

Our research and development expenses are charged to operations as incurred and we incur both direct and indirect expenses for each of our programs. We track direct research and development expenses by pre-clinical and clinical programs, which may include third-party costs such as costs related to Contract Research Organizations (“CROs”), contract laboratories, consulting, and clinical trial costs. We do not allocate indirect research and development expenses, which may include product development and manufacturing, clinical, medical, regulatory, laboratory (equipment and supplies), personnel, facility and other overhead costs, to specific programs.

Previous wording

During the three months ended March 31, 2025, total research and development expenses decreased by approximately $1.5 million, or 64%, as compared to the three months ended March 31, 2024. The following sets forth research and development expenses for the three months ended March 31, 2025 and 2024 by category:

Current wording

During the three months ended June 30, 2025, total research and development expenses decreased by approximately $2.6 million, or 80%, as compared to the three months ended June 30, 2024. During the six months ended June 30, 2025, total research and development expenses decreased by approximately $4.1 million, or 74%, as compared to the six months ended June 30, 2024. The reduction in research and development expenses is due to the decrease of costs associated with our legacy assets nomacopan and PHP-303 as we suspended the internal development of those programs while we prioritize our research and development activities on our ADC platform and pipeline. The following sets forth research and development expenses for the three and six months ended June 30, 2025 and 2024 by category:

Previous wording

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. The $0.6 million, or 90%, decrease in expenses incurred during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, is primarily due to our decision to suspend our HSCT-TMA clinical stage program with nomapocan in May 2024.

Current wording

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. The decrease in HSCT-TMA clinical development expenses of $0.4 million and $1 million, or 90% each, incurred during the three and six months ended June 30, 2025, respectively, as compared to the three and six months ended June 30, 2024, is primarily due to our decision to suspend the AK901 clinical program and find a collaborative partner for nomacopan program.

Previous wording

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 December 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.

Current wording

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.

Previous wording

These expenses historically included external expenses incurred related to the development and manufacturing of nomacopan for use in clinical trials and 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 manufacturing development activities. The $0.7 million, or 96%, decrease in expenses incurred during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, is primarily due to our decision to suspend our HSCT-TMA program in May 2024.

Current wording

CMC expenses historically included external expenses incurred related to the development and manufacturing of nomacopan for use in clinical trials and pre-clinical development of PAS-nomacopan. In general, such expenses primarily consist of payments to vendors for manufacturing of drug substance (including raw materials), drug product, supplies, validation, quality assurance and other manufacturing development activities. The decrease in expenses of $2.2 million and $2.9 million, or 99% and 98%, incurred during the three and six months ended June 30, 2025, respectively, as compared to the three and six months ended June 30, 2024, is primarily due to our decision to suspend our HSCT-TMA program and instead seek an external partner for further development.

Previous wording

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 $0.2 million, or 68%, decrease in expenses incurred during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, is primarily related to lower costs incurred related to preclinical studies and other development work investigating PAS-nomacopan for the treatment of GA.

Current wording

These expenses include external expenses, such as payments to contract vendors, that may be related to pre-clinical development activities, discontinued programs and unallocated expenses. During the three months ended June 30, 2025, we recovered certain expenses totaling less than $0.1 million resulting in a decrease of $0.4 million in expenses as compared to the three months ended June 30, 2024. The $0.6 million, or 94%, decrease in expenses incurred during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, is related to lower costs incurred related to pre-clinical studies and other pre-clinical development work investigating PAS-nomacopan for the treatment of GA.

Previous wording

These expenses include compensation and related costs associated with employees, independent consultants and staffing firms. The less than $0.1 million, or 3% decrease during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, is primarily due to lower cash-based salaries, offset by increases in non-cash stock based compensation expense.

Current wording

These expenses include compensation and related costs associated with employees, independent consultants and staffing firms. Personnel costs increased by $0.2 million, or 52%, and $0.2 million, or 16%, during the three and six months ended June 30, 2025, respectively, as compared to the three and six months ended June 30, 2024. The increase is primarily due to increases in non-cash stock-based compensation expense, partially offset by lower cash-based salaries.

Previous wording

During the three months ended March 31, 2025, total general and administrative costs decreased by approximately $1.0 million, or 27%, as compared to the three months ended March 31, 2024, primarily due to decreases in legal and professional fees of approximately $1.0 million (primarily related to the Merger) and a decrease of approximately $0.2 million in directors and officers insurance.

Current wording

During the three months ended June 30, 2025, total general and administrative costs increased by approximately $0.2 million, or 9%, as compared to the three months ended June 30, 2024, primarily due to an increase in non-cash stock-based compensation expense of $0.4 million, partially offset by a decrease of approximately $0.2 million in premiums for our directors and officers insurance.

Previous wording

During each of the three months ended March 31, 2025 and 2024, interest income was less than $0.1 million. Amounts may fluctuate from period to period due to changes in average cash balances and prevailing interest rates.

Current wording

During each of the three and six months ended June 30, 2025 and 2024, interest income was less than $0.1 million. Amounts may fluctuate from period to period due to changes in average cash balances and prevailing interest rates.

Previous wording

Interest expense primarily consists of interest incurred on the May 2024 Convertible Notes, the financing of director and officer insurance premiums and the notes assumed in the Merger, which include the April 2023 Convertible Notes, the November 2023 Note, the September 2024 Note and the Notes Payable, Related Party. Refer to Note 6 and Note 12 of our unaudited condensed consolidated financial statements included in this Form 10-Q.

Current wording

Interest expense primarily consists of interest incurred on the May 2024 Convertible Notes, the financing of director and officer insurance premiums and the notes assumed in the Merger, which include the April 2023 Convertible Notes, the November 2023 Note, the September 2024 Note, the 2021 Notes and the January 2024 Note. Refer to Note 6 and Note 12 of our unaudited condensed consolidated financial statements included in this Form 10-Q.

Previous wording

Interest expense may fluctuate from period to period due to changes in average interest-bearing loans and related interest rates. No interest expense was recognized during the three months ended March 31, 2024.

Current wording

Interest expense may fluctuate from period to period due to changes in average interest-bearing loans and related interest rates.

Previous wording

During the three months ended March 31, 2025, we recorded a gain on debt extinguishment related to our November 2022 Note of less than $0.1 million. Refer to Note 6 of our unaudited condensed consolidated financial statements included in this Form 10-Q. No such gain was recognized during the three months ended March 31, 2024.

Current wording

No such gain was recognized during the three and six months ended June 30, 2024.

Previous wording

During the three months ended March 31, 2025 and 2024, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation loss of less than $0.1 million and a non-cash revaluation gain of $0.6 million, respectively. Change in the fair value of warrant liabilities and resulting warrant revaluation loss for the three months ended March 31, 2025 was driven by the increase in our stock price and the increase in the expected volatility assumption, offset by decreases in the risk-free interest rate and the expected term assumption during the reporting period. Change in the fair value of warrant liabilities and resulting warrant revaluation gain for the three months ended March 31, 2024 was driven primarily by the decrease in our stock price and the decrease in the expected term assumption during the reporting period.

Current wording

During the three months ended June 30, 2025 and 2024, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation gain of approximately $0.1 million and a non-cash revaluation loss of $0.2 million, respectively. Change in the fair value of warrant liabilities and resulting warrant revaluation gain for the three months ended June 30, 2025 was driven by the decrease in our stock price during the reporting period. Changes in the fair value of the warrant liability and resulting warrant revaluation loss for the three months ended June 30, 2024 was driven primarily by the increase in our stock price during the reporting period.

Previous wording

During the three months ended March 31, 2025 and 2024, we recorded a net foreign currency exchange losses of approximately $0.1 million and $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.

Current wording

During the three months ended June 30, 2025 and 2024, we recorded a net foreign currency exchange loss of less than $0.1 million and net foreign currency gain of approximately $0.1 million, respectively. During the six months ended June 30, 2025 and 2024, we recorded a net foreign currency exchange loss of approximately $0.2 million and $0.1 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.

Previous wording

During each of the quarters ended March 31, 2025 and 2024, we recorded a net other expense of less than $0.1 million. Such expenses are not material to our results of operations.

Current wording

Other expense was less than $0.1 million during the six months ended June 30, 2024. During the three and six months ended June 30, 2025 and the three months ended June 30, 2024, we incurred no such expense. Other expenses are not material to our results of operations.

Previous wording

As a result of the factors discussed above, our net loss applicable to common shareholders for the three months ended March 31, 2025 was $3.7 million, compared to net loss applicable to ordinary shareholders for the three months ended March 31, 2024 of $5.6 million.

Current wording

As a result of the factors discussed above, our net loss applicable to common shareholders for the three months ended June 30, 2025 was $1.9 million, compared to net loss applicable to ordinary shareholders for the three months ended June 30, 2024 of $7.6 million. Our net loss applicable to common shareholders for the six months ended June 30, 2025 was $5.6 million, compared to net loss applicable to ordinary shareholders for the six months ended June 30, 2024 of $13.1 million.

Previous wording

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. At March 31, 2025, we had $2.6 million in cash and an accumulated deficit of $251.0 million. To date, we have not generated any revenue.

Current wording

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. At June 30, 2025, we had $2.7 million in cash and an accumulated deficit of $252.9 million. To date, we have not generated any revenue.

Previous wording

We currently do not have any commitments for future external funding. We will need to raise additional funds, and we may decide to raise additional funds even before we need such funds if the conditions for raising capital are available and/or favorable. Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financings, credit facilities or by out-licensing arrangements of our product candidates. The sale of equity or convertible debt securities may result in dilution to our existing shareholders. The incurrence of indebtedness would result in increased fixed obligations and could also subject us to covenants that restrict our operations. We cannot be certain that additional funding, whether through grants, financings, credit facilities or out-licensing arrangements, will be available to us on acceptable terms, if at all. If sufficient funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates, or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain potential products that we might otherwise seek to develop or commercialize independently.

Current wording

Other than with respect to the August 2025 Notes Offering, we currently do not have any commitments for future external funding. We will need to raise additional funds, and we may decide to raise additional funds even before we need such funds if the conditions for raising capital are available and/or favorable. Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financings, credit facilities or by out-licensing arrangements of our product candidates. The sale of equity or convertible debt securities may result in dilution to our existing shareholders. The incurrence of indebtedness would result in increased fixed obligations and could also subject us to covenants that restrict our operations. We cannot be certain that additional funding, whether through grants, financings, credit facilities or out-licensing arrangements, will be available to us on acceptable terms, if at all. If sufficient funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates, or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain potential products that we might otherwise seek to develop or commercialize independently.

Previous wording

At close of the November 2024 Private Placement, we incurred a total of $204,000 in placement agent fees with Paulson Investment Company, LLC (“Paulson”). Net proceeds from the November 2024 Private Placement were approximately $2.8 million after deducting placement agent fees and other expenses. In April 2025, we issued 408,000,000 ordinary shares to Paulson in lieu of $204,000 in cash payment.

Current wording

At close of the November 2024 Private Placement, we incurred a total of $204,000 in placement agent fees with Paulson. Net proceeds from the November 2024 Private Placement were approximately $2.8 million after deducting placement agent fees and other expenses. In April 2025, we issued 408,000,000 ordinary shares to Paulson in lieu of $204,000 in cash payment.

Previous wording

In October 2024, Drs. Prudo and Patel each elected to convert $125,000 of principal and accrued interest into our ADSs at a conversion price of $1.59 per ADS. These ordinary shares remain unissued as of December 31, 2024 and are expected to be issued during the second quarter of 2025. The remaining unconverted aggregate principal balance of the May 2024 Notes, or $750,000, was repaid in cash with proceeds from our U.K. research and development tax credit from HM Revenue and Customs.

Current wording

In October 2024, Drs. Prudo and Patel each elected to convert $125,000 of principal and accrued interest into our ADSs at a conversion price of $1.59 per ADS. These ordinary shares were issued during the six months ended June 30, 2025. The remaining unconverted aggregate principal balance of the May 2024 Notes, or $750,000, was repaid in cash with proceeds from our U.K. research and development tax credit from HM Revenue and Customs.

Previous wording

As of the date of this report, our existing cash, which includes $4.0 million in cash proceeds received from the March 2025 Private Placement subsequent to March 31, 2025, is sufficient to fund our operations into September 2025. While we have additional funding 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 and development collaborations, pre-clinical and clinical funding arrangements, the sale or license of technology assets, and/or other strategic alternatives.

Current wording

As of the date of this report, our existing cash, together with committed funds from the August 2025 Financing, is sufficient to fund our operations into October 2025. While we have additional funding 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 areunable 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 and development collaborations, pre-clinical and clinical funding arrangements, the sale or license of technology assets, and/or other strategic alternatives.

Previous wording

Operating Activities. The net cash used in operating activities for the periods presented consists primarily of our net loss adjusted for non-cash charges and changes in components of working capital. The decrease in cash used in operating activities during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, was primarily due to deferrals of payables in order to preserve cash until additional capital is raised for working capital purposes.

Current wording

*Operating Activities.*The net cash used in operating activities for the periods presented consists primarily of our net loss adjusted for non-cash charges and changes in components of working capital. The decrease in cash used in operating activities during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a decrease in research and development costs and restructuring costs related to the program reprioritization and a decrease in merger-related costs incurred in connection with the Peak Bio acquisition.

Previous wording

Investment Activities. There were no investing activities during the three months ended March 31, 2025 and 2024.

Current wording

Investment Activities. There were no investing activities during the six months ended June 30, 2025 and 2024.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

During the six months ended June 30, 2025 and 2024, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation gain of approximately $0.1 million and $0.5 million, respectively. Change in the fair value of warrant liabilities and resulting warrant revaluation gain for the six months ended June 30, 2025 was driven by the decrease in our stock price during the reporting period, offset by an extinguishment of liability related to certain September 2022 Warrants. Change in the fair value of warrant liabilities and resulting warrant revaluation gain for the six months ended June 30, 2024 was driven primarily by the decrease in our stock price and the decrease in the expected term assumption during the reporting period.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

Three Months Ended March 31, 2025 and 2024