Akari Therapeutics Plc
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout 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.
Sep 30, 2025 · Filed Nov 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 filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001493152-25-022390
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 122 previous paragraphs and 128 current paragraphs.
59 unchanged; 33 reworded; 35 added; 30 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 10 previous and 11 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 (35)
Current report
Presentation at 2025 Society for Immunotherapy of Cancer Annual Meeting
Current report
On November 10, 2025, we issued a press release announcing our abstract highlighting 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 unique results seen with both the single agent ADC Trastuzumab-PH1 and the combination therapy with an anti-PD1 agent open up the possibility of creating a new paradigm of an ADC/checkpoint inhibitor therapy that goes beyond today’s regimens using ADCs with traditional payloads.
Current report
Appointment of Interim Chief Financial Officer
Current report
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.
Current report
The Consulting Agreement provides for a monthly cash fee of $18,000 through the end of 2025 and a monthly cash fee of $27,000 starting January 1, 2026 through to February 15, 2026, pro-rated for any partial months. The Consulting Agreement also provides for the grant of RSU awards as follows: $4,645 in RSUs on October 22, 2025, which vested on October 31, 2025, $24,000 in RSUs on November 1, 2025 which vests on January 1, 2026 (subject to continued service through vesting) and $19,964 in RSUs on November 1, 2025, which vests on February 15, 2026 (subject to continued service through vesting). Further, in connection with certain capital raises by the Company, KDF Ventures shall be entitled to compensation payable in cash and RSUs based on a percentage of total gross proceeds, subject to maximum limits and depending on when the capital raise is completed. The Consulting Agreement provides for a term end date of February 16, 2026 and is extendable on a month-to-month basis at the Company’s discretion.
Current report
On October 16, 2025, we closed a registered direct offering (the “2025 Registered Direct Offering”) with certain institutional investors providing for the issuance and sale of 3,125,000 ADSs of the Company. The ADSs have been offered and sold together with series E warrants to purchase up to an aggregate of 3,125,000 ADSs (“Series E Warrants”) and series F warrants to purchase up to an aggregate of 3,125,000 ADSs (“Series F Warrants”, and, with the Series E Warrants, the “Warrants”), which are being issued in a concurrent private placement. The combined purchase price per each ADS and accompanying Warrants sold in the 2025 Registered Direct Offering was $0.80. The aggregate gross proceeds from the 2025 Registered Direct Offering were $2.5 million, excluding any proceeds from any future exercises of Warrants. For more information, please refer to “Financial Condition, Liquidity and Capital Resources– October 2025 Financing” below.
Current report
On August 29, 2025, we entered into an Ordinary Share Purchase Agreement (the “ELOC Purchase Agreement”) and Registration Rights (the “White Lion RRA”) with White Lion Capital, LLC, a Delaware limited liability company (“White Lion”). Pursuant to the ELOC Purchase Agreement, the Company had the right, but not the obligation, to require White Lion to purchase, from time to time, up to $25,000,000 in aggregate gross purchase price of newly issued Ordinary Shares, which may be exchanged for ADSs, subject to certain limitations and conditions set forth in the ELOC Purchase Agreement. For more information, please refer to “Financial Condition, Liquidity and Capital Resources – White Lion Ordinary Share Purchase and Registration Rights Agreements” below.
Current report
In August 2025, we entered into Note Purchase Agreements with certain investors, including the Company’s directors in a private placement offering pursuant to which the investors agreed to purchase, and 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 connection with the issuance and sale of the August 2025 Notes, the Company agreed to extend the expiration date of Series A Warrants held by certain August 2025 Note investors, previously issued in the March 2025 Private Placement, by 48 months from the original date of expiration. For more information, please refer to “Financial Condition, Liquidity and Capital Resources – August 2025 Financing” below.
Current report
Three and Nine Months Ended September 30, 2025 and 2024
Current report
We record receipts of U.K. tax credits in the year received as a reduction in research and development expenses. Changes in tax credits received are the result of eligible research and development expenses paid in the previous tax year, which can fluctuate depending on timing of and location in which expenses are incurred.
Current report
Impairment loss
Current report
During the three and nine months ended September 30, 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.
Current report
Loss on debt extinguishment
Current report
During the three and nine months ended September 30, 2025, we recognized a loss on extinguishment of debt of $1 million, of which $0.4 million was in relation to the issuance of the August 2025 Note to third party investors, $0.5 million was related to the cancellation and exchange of Dr. Huh’s January 2024 Note for his August 2025 Note and less than $0.1 million was related to the modification of the April 2023 Convertible Notes pursuant to the April 2023 Convertible Notes and Warrants Amendment (as defined and described in Note 7 to the Quarterly Financial Statements).
Current report
No such loss was recognized during the three and nine months ended September 30, 2024.
Current report
Loss on derivative liability
Current report
During the three and nine months ended September 30, 2025, we recognized expense of $0.1 million in relation to the embedded derivative in the White Lion ELOC.
Current report
No such loss was recognized during the three and nine months ended September 30, 2024.
Current report
October 2025 Financing
Current report
On October 16, 2025, the Company closed its 2025 Registered Direct Offering with certain institutional investors providing for the issuance and sale of 3,125,000 ADSs of the Company. The ADSs have been offered and sold together with Series E warrants to purchase up to an aggregate of 3,125,000 ADSs and Series F warrants to purchase up to an aggregate of 3,125,000 ADSs, which are being issued in a concurrent private placement. The combined purchase price per each ADS and accompanying Warrants sold in the 2025 Registered Direct Offering is $0.80. The aggregate gross proceeds from the 2025 Registered Direct Offering were $2.5 million, excluding any proceeds from any future exercises of Warrants.
Current report
The Series E Warrants have an exercise price of $0.98 per share, subject to customary adjustments as set forth therein, are exercisable commencing on the effective date (the “Shareholder Approval Date”) of shareholder approval of the issuance of the ADSs issuable upon exercise of the Warrants (the “Shareholder Approval”), and will have a 5-year term from the Shareholder Approval Date. The Series F Warrants have an exercise price of $0.98 per share, subject to customary adjustments as set forth therein, are exercisable on the Shareholder Approval Date, and will have a thirty-month term from the Shareholder Approval Date. If at the time of exercise there is no effective registration statement registering the ADSs underlying the Warrants, the Warrants may be exercised on a cashless basis. The Company has agreed to file a registration statement registering for resale the ADSs issuable upon exercise of the Warrants and the Placement Agent Warrants (defined below) within 30 days of the Closing Date.
Current report
The Company entered into a placement agency agreement (the “Placement Agent Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Placement Agent”), pursuant to which the Company paid $262,500 in cash at closing of the 2025 Registered Direct Offering. The Placement Agent also received warrants (the “Placement Agent Warrants”) on substantially the same terms as the Series E Warrants in an amount equal to 4.0% of the aggregate number of ADSs sold in the 2025 Registered Direct Offering to purchase up to 125,000 ADSs, at an exercise price of $1.00 per ADS and will have a 5-year term expiring October 14, 2030.
Current report
On August 29, 2025, the Company entered into the ELOC Purchase Agreement and White Lion RRA with White Lion Capital. Pursuant to the ELOC Purchase Agreement, the Company had the right, but not the obligation, to require White Lion to purchase, from time to time, up to $25,000,000 in aggregate gross purchase price of newly issued Ordinary Shares, which may be exchanged for ADSs, subject to certain limitations and conditions set forth in the ELOC Purchase Agreement.
Current report
The Company does not have a right to commence any sales of Ordinary Shares to White Lion under the ELOC Purchase Agreement until all conditions to the Company’s right to commence sales, as set forth in the ELOC Purchase Agreement, have been satisfied, including that a registration statement covering the resale of such shares is declared effective by the SEC and the final form of prospectus is filed with the SEC. Over the period ending on the earlier of (i) the date on which the Purchaser shall have purchased Ordinary Shares pursuant to the ELOC Purchase Agreement for an aggregate purchase price equal to the Commitment Amount or (ii) August 29, 2028 (the “Commitment Period”), subject to the conditions of the ELOC Purchase Agreement, the Company will control the timing and amount of any sales of Ordinary Shares to the Purchaser. Actual sales of Ordinary Shares to the Purchaser under the ELOC Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the ADSs, and determinations made by the Company as to appropriate levels and sources of funding.
Current report
The purchase price of the Ordinary Shares that the Company elects to sell to the Purchaser pursuant to the ELOC Purchase Agreement will be determined based on the type of Purchase Notice issued, as follows:
Current report
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). In any event, the ELOC Purchase Agreement provides that the Company may not issue or sell any Ordinary Shares if such issuance or sale would breach any applicable Nasdaq rules.
Current report
The ELOC Purchase Agreement prohibits the Company from directing the Purchaser to purchase any Ordinary Shares if those shares, when aggregated with all other Ordinary Shares then beneficially owned by the Purchaser (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended), would result in the Purchaser beneficially owning more than 4.99% of the outstanding Ordinary Shares (the “Beneficial Ownership Limitation”), which may be increased to 9.99% at the Purchaser’s discretion upon 61 days’ prior written notice.
Current report
As consideration for the Purchaser’s execution of the ELOC Purchase Agreement, the Company will pay a document preparation fee of $15,000, to be deducted from the proceeds related to the first Purchase Notice, and cash commitment fees of $37,500 when aggregate Purchase Notices exceed $500,000 and $87,500 (or $125,000 if $1,000,000 is reached first) when aggregate Purchase Notices exceed $1,000,000. Additionally, if the Company fails to close at least $625,000 in purchases by the 180th day after the Registration Statement’s effective date, the Company will issue ADSs, represented by Ordinary Shares, equivalent to $75,000 divided by the lowest traded ADS price during a 10-day period preceding that date (the “Commitment Shares”).
Current report
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.
Current report
As of September 30, 2025, the Company had no outstanding purchase notices issued to White Lion.
Current report
August 2025 Financing
Current report
In August 2025, we entered into Note Purchase Agreements with certain investors, including the Company’s directors in a private placement offering pursuant to which the investors agreed to purchase, and the Company agreed to issue unsecured promissory notes with a 20% original issuance discount. In connection with the issuance and sale of the August 2025 Notes, the Company agreed to extend the expiration date of Series A Warrants held by certain August 2025 Note investors, previously issued in the March 2025 Private Placement, by 48 months from the original date of expiration.
Current report
We issued August 2025 Notes with an aggregate purchase price of $3,011,000 and an aggregate principal amount of $3,763,750, inclusive of the Note Termination (described below). The August 2025 Notes have maturity dates ranging from August 15, 2026, through September 26, 2026, at which time the principal amount is due and payable. The Company also entered into Warrant Amendment Agreements with the recipients of such August 2025 Notes, which extended the expiration date of the Series A Warrants to purchase an aggregate of 6,864,483 ADSs held by such investors from 2026 to 2030.
Current report
Included in the issued Notes with an aggregate purchase price of $3,011,000 and an aggregate principal amount of $3,763,750, as outlined above, Dr. Hoyoung Huh, the Company’s Chairman, purchased a 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 the payment of $162,567 in cash and the cancellation of $837,433 of outstanding principal and accrued interest under a senior secured promissory note previously issued to him by the Company’s wholly owned subsidiary, Peak Bio Inc., in January 2024.
Current report
We paid a placement agent fee of $75,000 to Paulson in connection with the August 2025 Notes Offering.
Removed paragraphs (30)
Previous 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.
Previous 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.
Previous report
Appointment of New President and Chief Executive Officer
Previous report
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 report
March 2025 Private Placement
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous report
Pipeline Prioritization of the Merged Companies
Previous report
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 report
Restructuring and Reduction-in-Force
Previous report
In May 2024, we implemented a reduction-in-force (the “RIF”) of approximately 67% of our total workforce, as a result of the previously announced program prioritization under which our nomacopan HSCT-TMA program was suspended. The RIF was part of an operational restructuring plan and included 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 to Note 14 of our unaudited condensed consolidated financial statements included in this Form 10-Q.
Previous report
Three and Six Months Ended June 30, 2025 and 2024
Previous 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.
Previous 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.
Previous report
March 2025 Private Placement
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous report
November 2024 Private Placement
Previous report
In November 2024, we entered into a definitive purchase agreement with certain investors, Dr. Ray Prudo and Dr. Samir Patel, pursuant to which we sold and issued in a private placement an aggregate of 1,713,402 ADSs, and Series D Warrants (the “Series D Warrants”) to purchase up to 1,713,402 ADSs, at a per unit price of $2.26 for aggregate gross proceeds of $3.2 million (the “November 2024 Private Placement”). The Series D Warrants have 3-year terms ranging from December 2, 2027 to June 2, 2028 and have cashless exercise provisions in limited circumstances.
Previous report
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 report
May 2024 Private Placement
Previous report
In May 2024, we entered into a definitive purchase agreement with certain investors, Dr. Ray Prudo and Dr. Samir Patel, pursuant to which we sold and issued in a private placement an aggregate of 4,029,754 ADSs, and May 2024 Series C Warrants (the “Series C Warrants”) to purchase up to 4,029,754 ADS, at a per unit price of $1.885 per ADS and Series C Warrant for aggregate gross proceeds of approximately $7.6 million (the “May 2024 Private Placement”). The Series C Warrants have 3-year terms ranging from May 31, 2027 to June 21, 2027 and have cashless exercise provisions in limited circumstances. The Series C Warrants (other than those issued to Dr. Prudo and Dr. Patel) have an exercise price of $1.76 per ADS. The Series C Warrants issued to Dr. Prudo and Dr. Patel have an exercise price of $1.79 per ADS. Net proceeds from the May 2024 Private Placement were approximately $7.0 million after deducting placement agent fees and other expenses.
Previous report
May 2024 Convertible Notes
Previous report
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 report
March 2024 Private Placement
Previous report
In March 2024, we entered into a definitive purchase agreement with certain existing investors, pursuant to which we sold and issued in a private placement an aggregate of 1,320,614 ADSs at $1.48 per ADS, for aggregate gross proceeds of approximately $2.0 million (the “March 2024 Private Placement”). Net proceeds from the March 2024 Private Placement were approximately $1.7 million after deducting placement agent fees and other expenses.
Reworded paragraphs (33)
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. 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.
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 Folate Receptor 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.
Previous 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.
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 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.
Previous 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.
Current wording
We acquired the ADC Platform in connection with our acquisition of Peak Bio (the “Merger”) in November 2024. 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.
Previous 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:
Current wording
During the three months ended September 30, 2025, our loss from operations totaled $7.4 million, including a $5.18 million non-cash impairment loss on other intangible assets, a 153% increase, compared to a loss from operations of $2.9 million for the three months ended September 30, 2024. During the nine months ended September 30, 2025, our loss from operations totaled $14.0 million, a 14% decrease, compared to a loss from operations of $16.4 million for the nine months ended September 30, 2024. Our total operating expenses are set forth by category in the table below:
Previous 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:
Current wording
During the three months ended September 30, 2025, total research and development expenses increased by approximately $0.1 million, as compared to the three months ended September 30, 2024. During the nine months ended September 30, 2025, total research and development expenses decreased by approximately $4.0 million as compared to the nine months ended September 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 nine months ended September 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 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.
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 $0.5 million and $1.5 million incurred during the three and nine months ended September 30, 2025, respectively, as compared to the three and nine months ended September 30, 2024, is primarily due to our decision to suspend the AK901 clinical program and find a collaborative partner for our nomacopan program.
Previous 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.
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 $0.4 million and $3.3 million incurred during the three and nine months ended September 30, 2025, respectively, as compared to the three and nine months ended September 30, 2024, is primarily due to our decision to suspend our pre-clinical PAS-nomacopan 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 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.
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. The decrease in expenses of $0.1 million and $0.7 million incurred during the three and nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, is related to lower costs incurred mainly 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. 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.
Current wording
These expenses include compensation and related costs associated with employees, independent consultants and staffing firms. Personnel costs decreased by less than $0.1 million during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024. Personnel costs increased by less than $0.1 million during the nine months ended September 30, 2025 as compared to the nine months ended September 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
In May 2024, we entered into unsecured convertible promissory notes (the “May 2024 Notes”) with Dr. Prudo, our Chairman at the time, and our then Interim President and Chief Executive Officer and director, Dr. Patel, for an aggregate of $1.0 million in gross proceeds. The May 2024 Notes bear interest at 15% per annum, which may be increased to 17% upon the occurrence of certain events of default as described therein, and the principal and all accrued but unpaid interest is due on the date that is the earlier of (a) ten (10) business days following our receipt of a U.K. research and development tax credit from HM Revenue and Customs, and (b) November 10, 2024. Provided, however, at any time or times from the date of the note and until the tenth business day prior to closing of the acquisition, the note holders are entitled to convert any portion of the outstanding and unpaid amount, including principal and accrued interest, into our ADSs at a fixed conversion price equal to $1.59, representing the Nasdaq official closing price of our ADSs on the issuance date, subject to certain restrictions.
Current wording
U.K Research and Development Tax Credit
Previous 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.
Current wording
During the three months ended September 30, 2025, total general and administrative costs increased by approximately $0.3 million as compared to the three months ended September 30, 2024, primarily due to an increase in non-cash stock-based compensation expense of $0.4 million, an increase of less than $0.1 million in professional fees mainly related to implementation of the ELOC Purchase Agreement with White Lion, and partially offset by a decrease of approximately $0.2 million in premiums for our directors and officers insurance.
Previous wording
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 wording
During the nine months ended September 30, 2025, total general and administrative costs increased by approximately $0.5 million as compared to the nine months ended September 30, 2024, primarily due to an increase in non-cash stock-based compensation expense of $1.1 million, an increase of $0.3 million in professional fees (primarily driven from Merger related financial disclosures and implementation of the ELOC Purchase Agreement with White Lion), 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.
Previous wording
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 wording
Merger-related costs for the three and nine months ended September 30, 2024 were $1 million and $2.3 million, respectively. No such costs were incurred during three and nine months ended September 30, 2025.
Previous wording
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 wording
Restructuring costs consist primarily of severance and related benefit costs related to workforce reductions incurred in connection with the reduction in force (“RIF”), which the Company began to implement in May 2024.
Previous wording
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 wording
Restructuring and other costs for the three and nine months ended September 30, 2024 were less than $0.1 million and $1.7 million, respectively. No such costs were incurred during three and nine months ended September 30, 2025.
Previous 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.
Current wording
During each of the three and nine months ended September 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, 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.
Current wording
Interest expense primarily consists of amortization of share issuance costs on the August 2025 Notes and interest expense on the May 2024 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 7 and Note 13 of our unaudited condensed consolidated financial statements included in this Form 10-Q (the “Quarterly Financial Statements”).
Previous wording
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 wording
During the three months ended September 30, 2025, we recognized a gain on settlement of current liabilities of $0.8 million with a vendor.
Previous wording
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 wording
During the nine months ended September 30, 2025, we recognized a gain on settlement of current liabilities of $2.0 million which is comprised of a gain on settlement of $1.9 million with former vendors 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.
Previous wording
No such gain was recognized during the three and six months ended June 30, 2024.
Current wording
No such gain was recognized during the three and nine months ended September 30, 2024.
Previous wording
Change in fair value of warrant liabilities represents non-cash warrant revaluation gains or losses related to the remeasurement of our liability-classified instruments, namely our September 2022 Warrants and the warrants we assumed on November 14, 2024 in connection with our acquisition of Peak Bio (the “Peak Bio Warrants”), which are more fully described in Note 4 of our condensed consolidated financial statements included in this Form 10-Q. 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 remeasurement 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.
Current wording
Change in fair value of warrant liabilities represents non-cash warrant revaluation gains or losses related to the remeasurement of our liability-classified instruments, namely our September 2022 Warrants and the warrants we assumed on November 14, 2024 in connection with our acquisition of Peak Bio (the “Peak Bio Warrants”), which are more fully described in Note 5 to the Quarterly Financial Statements. 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 remeasurement 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.
Previous 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.
Current wording
During the three months ended September 30, 2025 and 2024, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation gain of approximately $0.3 million and $0.1 million, respectively. Changes in the fair value of warrant liabilities and resulting warrant revaluation gain for the three months ended September 30, 2025 and 2024 were driven by the decrease in our stock price during the respective reporting period.
Previous wording
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.
Current wording
During the nine months ended September 30, 2025 and 2024, we recorded a change in the fair value of warrant liabilities, representing a non-cash revaluation gain of approximately $0.3 million and $0.5 million, respectively. Change in the fair value of warrant liabilities and resulting warrant revaluation gain for the nine months ended September 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 and reclassification of certain Peak Warrants from warrant liability to equity following amendment of certain Peak Bio Warrants. Change in the fair value of warrant liabilities and resulting warrant revaluation gain for the nine months ended September 30, 2024 was driven primarily by the decrease in our stock price and the decrease in the expected term assumption during the reporting period.
Previous 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.
Current wording
During each of the three months ended September 30, 2025 and 2024, we recorded a net foreign currency exchange gain of less than $0.1 million. During each of the nine months ended September 30, 2025 and 2024, we recorded a net foreign currency exchange loss of less than $0.1 million. 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
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.
Current wording
Other expense was less than $0.1 million during the nine months ended September 30, 2024. During the three and nine months ended September 30, 2025 and the three months ended September 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 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.
Current wording
As a result of the factors discussed above, our net loss applicable to common shareholders for the three months ended September 30, 2025 was $6.4 million, compared to net loss applicable to ordinary shareholders for the three months ended September 30, 2024 of $2.9 million. Our net loss applicable to common shareholders for the nine months ended September 30, 2025 was $12.0 million, compared to net loss applicable to ordinary shareholders for the nine months ended September 30, 2024 of $16.0 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 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.
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 September 30, 2025, we had $2.5 million in cash and an accumulated deficit of $259.3 million. To date, we have not generated any revenue.
Previous 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.
Current wording
Other than under the ELOC Purchase Agreement, the use of which is subject to the effectiveness of the registration statement we filed with the SEC pursuant to the White Lion RRA, 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
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.
Current wording
As of the date of this report, our existing cash, together with funds from the October 2025 Financing, is sufficient to fund our operations into December 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
Based on our recurring losses from operations incurred since inception, our expectation of continuing operating losses for the foreseeable future, negative operating cash flows for the foreseeable future, and the need to raise additional capital to finance its future operations, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date that our condensed consolidated financial statements, included in this Form 10-Q (such condensed consolidated financial statements, the “consolidated financial statements”) are issued. Because of these uncertainties, the accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As such, the accompanying consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary if we are unable to continue as a going concern.
Current wording
Based on our recurring losses from operations incurred since inception, our expectation of continuing operating losses for the foreseeable future, negative operating cash flows for the foreseeable future, and the need to raise additional capital to finance its future operations, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date that our Quarterly Financial Statements are issued. Because of these uncertainties, the accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As such, the accompanying consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary if we are unable to continue as a going concern.
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 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.
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 nine months ended September 30, 2025, as compared to the nine months ended September 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 six months ended June 30, 2025 and 2024.
Current wording
Investment Activities. There were no investing activities during the nine months ended September 30, 2025 and 2024.
Previous wording
In November 2024 as part of the Merger, we assumed convertible notes and notes payable with third parties, and notes payable with a related party, through the acquisition of Peak Bio Inc., as more fully described in Note 6 and Note 12, respectively, to our unaudited condensed consolidated financial statements appearing in this Form 10-Q. As of June 30, 2025, these obligations are expected to result in principal payments of approximately $1.6 million.
Current wording
We have outstanding convertible notes and notes payable with third parties and related parties assumed from the acquisition of Peak Bio Inc. and through new financings as more fully described in Note 7 and Note 13, respectively, to our Quarterly Financial Statements. As of September 30, 2025, these obligations are expected to result in principal payments of approximately $4.6 million.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The extent of our future research and development expenditures will be determined based on future funding and location of work performed.