Akari Therapeutics Plc 10-Q for FY2025 Q1
Akari Therapeutics Plc (AKTX)
About this 10-Q
Akari Therapeutics Plc filed this 10-Q on May 14, 2025, covering the quarter ended March 31, 2025 (FY2025 Q1).
Headline figures
Quarter ended March 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $3.71M
- compared with a net loss of $5.57M a year earlier
- Diluted EPS
- $0.00
- compared with $0.00 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ |
Commission File Number
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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* Trading, but only in connection with the American Depositary Shares.
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO
The number of shares of Registrant’s Ordinary Shares outstanding as of May 9, 2025 was
TABLE OF CONTENTS
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PART I |
1 |
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Item 1. |
1 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
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Condensed Consolidated Statements of Shareholders' Equity (Deficit) |
3 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
23 |
Item 3. |
35 |
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Item 4. |
36 |
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PART II |
37 |
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Item 1. |
37 |
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Item 1A. |
37 |
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Item 2. |
37 |
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Item 3. |
37 |
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Item 4. |
37 |
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Item 5. |
37 |
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Item 6. |
38 |
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39 |
i
GENERAL INFORMATION
Unless otherwise stated or the context requires otherwise, references in this Quarterly Report on Form 10-Q ( “Form 10-Q”) to “Akari,” the “company,” the “Company,” “we,” “us,” “our” or similar designations refer to Akari Therapeutics, Plc and its subsidiaries, taken together. All trademarks, service marks, trade names and registered marks used in this report are trademarks, trade names or registered marks of their respective owners.
Statements made in this Form 10-Q concerning the contents of any agreement, contract or other document are summaries of such agreements, contracts or documents and are not complete description of all of their terms. If we filed any of these agreements, contracts or documents as exhibits to this Form 10-Q or to any previous filing with the Securities and Exchange Commission (“SEC”), you may read the document itself for a complete understanding of its terms.
ii
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Form 10-Q and the documents we incorporate by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical fact, included or incorporated in this report regarding, among other things, our cash resources and projected cash runway, financial position, our strategy, strategic alternatives, future operations, clinical trials (including, without limitation, the anticipated timing enrollment, and results thereof), collaborations, intellectual property, future revenues, projected costs, fundraising and/or financing plans, prospects, developments relating to our competitors and our industry, the timing or likelihood of regulatory actions, filings and approvals for our current and future drug candidates, and the plans and objectives of management are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “intend,” “continue,” “will,” “schedule,” “would,” “aim,” “contemplate,” “estimate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we will actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond our control, and which may cause the actual results, performance, or achievements of the Company to be materially different from future results, performance, or achievements expressed or implied by such forward-looking statements.
There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements. These important factors include those set forth under Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 (our “Form 10-K”) and Part II “Item 1A. Risk Factors” of this Form 10-Q and in our other disclosures and filings we have made with the SEC. These factors and the other cautionary statements made in this Form 10-Q and the documents we incorporate by reference should be read as being applicable to all related forward-looking statements whenever they appear in this Form 10-Q and the documents we incorporate by reference.
In addition, any forward-looking statements represent our estimates only as of the date that this Form 10-Q is filed with the SEC and should not be relied upon as representing our estimates as of any subsequent date. All forward-looking statements included in this Form 10-Q are made as of the date hereof and are expressly qualified in their entirety by this cautionary notice. We disclaim any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required by law.
iii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited).
AKARI THERAPEUTICS, PLC
Condensed Consolidated Balance Sheets
(Amounts in thousands, except share and per share data)
(unaudited)
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March 31, |
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December 31, |
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2025 |
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2024 |
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ASSETS |
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Current assets: |
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Cash |
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$ |
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$ |
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Restricted cash |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Goodwill |
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Other intangible assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Convertible notes |
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Convertible notes, related party |
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Notes payable |
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Notes payable, related party |
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Warrant liabilities |
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Liability related to deposits received for share subscriptions |
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— |
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Other current liabilities |
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Total current liabilities |
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Other non-current liabilities |
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Deferred tax liability |
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Total liabilities |
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(Note 13) |
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Shareholders’ equity: |
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Share capital of $ |
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Authorized: |
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Additional paid-in capital |
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Capital redemption reserve |
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Accumulated other comprehensive loss |
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( |
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( |
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Accumulated deficit |
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( |
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( |
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Total shareholders’ equity |
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Total liabilities and shareholders' equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
AKARI THERAPEUTICS, PLC
Condensed Consolidated Statements of Operations
and Comprehensive Loss
(amounts in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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March 31, |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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Other income (expense): |
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Interest income |
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— |
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Interest expense |
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( |
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— |
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Gain on debt extinguishment |
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— |
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Change in fair value of warrant liabilities |
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( |
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Foreign currency exchange loss, net |
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( |
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( |
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Other expense, net |
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— |
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( |
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Total other (expense) income, net |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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Net loss per share –– basic and diluted |
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$ |
( |
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$ |
( |
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Weighted-average number of ordinary shares used in computing net loss per share –– basic and diluted |
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Comprehensive loss: |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive (loss) income, net of tax: |
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Foreign currency translation adjustment |
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( |
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Total other comprehensive (loss) income, net of tax |
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( |
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Total comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
AKARI THERAPEUTICS, PLC
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit)
(amounts in thousands, except share data)
(unaudited)
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Three Months Ended March 31, 2025 |
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Accumulated |
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Additional |
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Capital |
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Other |
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Total |
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Share Capital $ |
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Paid-in- |
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Redemption |
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Comprehensive |
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Accumulated |
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Shareholders' |
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Shares |
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Amount |
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Capital |
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Reserve |
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Loss |
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Deficit |
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Equity |
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Balance, December 31, 2024 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Issuance of share capital related to |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Foreign currency translation |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance, March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Three Months Ended March 31, 2024 |
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Accumulated |
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Additional |
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Capital |
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Other |
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Total |
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Share Capital $ |
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Paid-in- |
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Redemption |
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Comprehensive |
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Accumulated |
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Shareholders' |
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Shares |
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Amount |
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Capital |
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Reserve |
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(Income) Loss |
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Deficit |
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Equity (Deficit) |
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Balance, December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Issuance of share capital related to |
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— |
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— |
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— |
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Vesting of restricted shares |
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( |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Foreign currency translation |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance, March 31, 2024 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
AKARI THERAPEUTICS, PLC
Condensed Consolidated Statements of Cash Flows
(amounts in thousands)
(unaudited)
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Three Months Ended |
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March 31, |
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2025 |
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2024 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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— |
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Stock-based compensation |
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Gain on debt extinguishment |
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( |
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— |
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Change in fair value of warrant liabilities |
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( |
) |
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Unrealized foreign currency exchange (gains) losses |
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( |
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Change in assets and liabilities: |
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Prepaid expenses and other current assets |
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Accounts payable and accrued expenses |
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Net cash used in operating activities |
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( |
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( |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of shares, net of issuance costs |
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Proceeds from employee vesting of restricted shares |
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— |
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Proceeds from deposits received for share subscriptions |
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— |
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Repayments of notes payable |
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( |
) |
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— |
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Payments on short-term financing arrangement |
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( |
) |
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( |
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Net cash provided by financing activities |
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Effect of exchange rates on cash |
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— |
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( |
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Net change in cash |
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( |
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( |
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Cash and restricted cash at beginning of period |
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Cash and restricted cash at end of period |
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$ |
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$ |
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Components of cash and restricted cash |
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Cash |
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$ |
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$ |
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Restricted cash |
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— |
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Total cash and restricted cash |
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$ |
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$ |
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SUPPLEMENTAL DISCLOSURES OF NONCASH ACTIVITIES: |
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Financing costs in accrued expenses |
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$ |
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$ |
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Financing costs, deposits received for share subscriptions in accounts payable |
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$ |
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$ |
— |
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Issuance of share capital for settlement of related party debt |
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$ |
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$ |
— |
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Seller-financed purchases |
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$ |
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$ |
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SUPPLEMENTAL CASH FLOW DISCLOSURES: |
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Cash paid for interest |
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$ |
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$ |
— |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
AKARI THERAPEUTICS, PLC
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 1. Description of Business
Business Overview
Akari Therapeutics, Plc, (the “Company” or “Akari”) is incorporated in the United Kingdom. The Company is developing next-generation antibody-drug conjugates, or ADCs, through its proprietary technology platform that enables Akari to generate a range of ADC candidates and optimize them to target a range of cancers. On March 4, 2024, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Peak Bio, Inc. (“Peak Bio”) and Pegasus Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Akari (“Merger Sub”). On November 14, 2024, the Company completed the previously announced strategic business combination contemplated by the Merger Agreement (“Closing”), pursuant to which, Merger Sub merged with and into Peak Bio, with Peak Bio surviving the acquisition as a wholly owned subsidiary of Akari.
Since the Company’s acquisition of Peak Bio in November 2024, Akari has focused substantially all of its efforts on the ADC platform and pipeline of novel anti-cancer payloads with mechanisms of action that differ from existing therapies and the application of those payloads against clinically validated targets. Through its platform, the Company aims to establish a pipeline of ADC candidates that target and kill cancer cells and stimulate the immune system, all while overcoming the limitations inherent in existing therapies. The Company’s activities since inception have consisted of performing research and development activities and raising capital.
The Company is subject to a number of risks similar to those of preclinical and clinical stage companies, including dependence on key individuals, uncertainty of product development and generation of revenues, dependence on outside sources of capital, risks associated with clinical trials of products, dependence on third-party collaborators for research and development operations, need for marketing authorization of products, risks associated with protection of intellectual property, and competition with larger, better-capitalized companies.
To fully execute its business plan, the Company will need, among other things, to complete its research and development efforts, preclinical and regulatory activities, and clinical trials. These activities may take several years and will require significant operating and capital expenditures in the foreseeable future. There can be no assurance that these activities will be successful. If the Company is not successful in these activities it could delay, limit, reduce or terminate its preclinical studies or other discovery and research activities.
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and the rules and regulations of the SEC and assumes that the Company will continue to operate as a going concern. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, including normal and recurring adjustments, which the Company considers necessary for the fair statement of financial information. The results of operations and comprehensive loss for the three months ended March 31, 2025 are not necessarily indicative of expected results for the fiscal year ending December 31, 2025 or any other future period. The condensed balance sheet at December 31, 2024 has been derived from the audited consolidated financial statements at that date. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements as of December 31, 2024 and notes thereto included in its Form 10-K, as filed with the SEC on April 15, 2025.
5
Use of estimates
The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets, liabilities, expenses and related disclosures. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the valuation of share-based awards, the valuation of warrant liabilities, the valuation of goodwill and indefinite-lived intangible assets, research and development prepayments, accruals and related expenses, and the valuation allowance for deferred income taxes. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed considering changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.
Liquidity and Financial Condition
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements—Going Concern, which requires management to assess the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued.
The Company has incurred substantial losses and negative cash flows since inception and had an accumulated deficit of $
The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in research and development. The Company is subject to a number of risks and uncertainties similar to those of other companies of the same size within the biotechnology industry, such as uncertainty of preclinical research outcomes, uncertainty of additional funding, and history of operating losses. Substantial additional financing will be needed by the Company to fund its operations. Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include, but are not limited to: private placements and/or public offerings of equity and/or debt securities, and strategic research and development collaborations and/or similar arrangements. There can be no assurance that these future funding efforts will be successful.
6
Note 2. Summary of Significant Accounting Policies
The significant accounting policies and estimates used in the preparation of the accompanying unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2025. There have been no material changes in the Company’s significant accounting policies during the three months ended March 31, 2025.
Recent accounting pronouncements
Periodically, new accounting pronouncements are issued by the FASB or other standard setting bodies. Recently issued standards typically do not require adoption until a future effective date. Prior to their effective date, we evaluate the pronouncements to determine the potential effects of adoption on our accompanying unaudited consolidated financial statements. During the first three months of 2025, no new accounting pronouncements issued or effective in the period had or are expected to have a material impact on our accompanying unaudited consolidated financial statements.
Note 3. Agreement and Plan of Merger
In connection with the November 14, 2024 acquisition of Peak Bio, the Company issued a total of
At the Closing, each Peak Warrant and Peak Option was converted into an Adjusted Warrant and Adjusted Option to purchase a number of Akari ordinary shares or Akari ADSs, based on the Exchange Ratio. The Adjusted Warrants and the Adjusted Options have substantially similar terms and conditions as were applicable to such Peak Warrants and Peak Options immediately prior to the Closing.
Consideration Paid
The following table summarizes the total consideration paid pursuant to the Merger Agreement, which was based on the closing market price of Akari's ADS as of the
($ in thousands) |
|
Number of ADSs issued and issuable on exercise |
|
|
Consideration |
|
||
Company ADSs issued to Peak Bio Inc. shareholders |
|
|
|
|
$ |
|
||
Company ADSs issuable on exercise of November 2022 Peak Investor Warrants and April 2023 Peak Investor Warrants |
|
|
|
|
|
|
||
Company ADSs issuable on exercise of Peak Bio Adjusted Options |
|
|
|
|
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— |
|
|
Total consideration |
|
|
|
|
$ |
|
||
The fair value of the
In connection with the acquisition of Peak Bio, the Company assumed (i) warrants issued to investors (“November 2022 Peak Warrants”) to purchase an aggregate of
7
The Company determined that the November 2022 Peak Warrants and the April 2023 Peak Warrants are not indexed to the Company’s own stock in the manner contemplated by the relevant accounting standard. Accordingly, on the Closing of the acquisition, the Company classified these warrants as derivative liabilities in its consolidated balance sheets.
The estimated fair value of the Adjusted Warrants of $
|
|
Peak Bio Assumed Warrants |
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|||||
|
|
November 2022 |
|
|
April 2023 |
|
|
||
Stock (ADS) price |
|
$ |
|
|
$ |
|
|
||
Exercise price |
|
$ |
|
|
$ |
|
|
||
Expected term (in years) |
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|
|
|
|
|
||
Expected volatility |
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|
% |
|
|
% |
|
||
Risk-free interest rate |
|
|
% |
|
|
% |
|
||
Expected dividend yield |
|
|
— |
|
|
|
— |
|
|
The Company assumed Peak Bio's outstanding stock option awards and granted options to purchase
Total Assets Acquired and Liabilities Assumed
The acquisition of Peak Bio has been accounted for as a business combination using the acquisition method of accounting. The fair value of the purchase price was allocated to the assets acquired and liabilities assumed at their respective fair values. Management estimated the fair value of the IPR&D intangible assets using a multi-period excess earnings method. The significant assumptions used in the valuation are the probability of clinical trial success and obtaining regulatory approval, forecasted gross sales from up-front and milestone payments, royalties and product sales, and the discount rate reflecting the Company's weighted average cost of capital. This acquisition method requires, among other things, that assets acquired, and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date.
The following table summarizes the final fair values of assets acquired and liabilities assumed as of the acquisition date (in thousands):
8
Assets acquired |
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|
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Cash and restricted cash |
|
$ |
|
|
Prepaid expenses and other current assets |
|
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|
|
Acquired in-process research and development |
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|
Total assets acquired |
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Liabilities assumed |
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Accounts payable and accrued expenses |
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Convertible notes |
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Notes payable |
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Notes payable, related party |
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Deferred tax liability |
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|
Total liabilities assumed |
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|
Total assets acquired and liabilities assumed |
|
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|
|
Goodwill |
|
|
|
|
Net assets acquired |
|
$ |
|
|
Intangible assets of approximately $
There were no changes to the carrying value of goodwill and other intangible assets during the three months ended March 31, 2025.
The fair value of IPR&D intangible assets was as follows (in thousands):
In-Process Research and Development |
|
|
|
|
AKTX 101 |
|
$ |
|
|
PHP 303 |
|
|
|
|
Total in-process research and development |
|
$ |
|
|
The Company assumed convertible notes and notes payable with third parties, and notes payable with a related party, which are described in Note 6 and Note 12, respectively.
Pro Forma Financial Information (Unaudited)
The following table summarizes certain of the Company's supplemental pro forma financial information for the three months ended March 31, 2024, as if the acquisition of Peak Bio had occurred as of January 1, 2024. The unaudited pro forma financial information for the three months ended March 31, 2024 reflect (i) the reversal of fair value adjustments recognized on Peak Bio's warrant liabilities and derivative liability, and (ii) the reversal of interest and accretion expense on Peak Bio's debt that was settled on the acquisition date.
|
|
Three Months Ended March 31, 2024 |
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|||||
|
|
As Reported |
|
|
Pro Forma |
|
|
||
Net loss |
|
$ |
( |
) |
|
|
( |
) |
|
Note 4. Fair Value Measurements
Assets and Liabilities Measured at Fair Value on a Recurring Basis
9
The following table presents information about the Company’s financial liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy used to determine such values:
|
|
March 31, 2025 |
|
|||||||||||||
(In thousands) |
|
Total |
|
|
Level 1 |
|
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Level 2 |
|
|
Level 3 |
|
||||
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability - November 2022 Peak Warrants |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Warrant liability - April 2023 Peak Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Warrant liability - September 2022 Series B |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
December 31, 2024 |
|
|||||||||||||
(In thousands) |
|
Total |
|
|
Level 1 |
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Level 2 |
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Level 3 |
|
||||
Liabilities |
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|
|
|
|
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|
|
|
|
|
||||
Warrant liability - November 2022 Peak Warrants |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Warrant liability - April 2023 Peak Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Warrant liability - September 2022 Series B |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
The Company’s Level 3 liabilities consist of the September 2022 Warrants, the November 2022 Peak Warrants and the April 2023 Peak Warrants, which were determined to be liability-classified instruments. There were no transfers between Level 1, Level 2, and Level 3 during the three months ended March 31, 2025 and the year ended December 31, 2024.
Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis
The following table summarizes the activity in the warrant liabilities measured at fair value on a recurring basis using unobservable inputs (Level 3) during the three months ended March 31, 2025:
|
|
Warrant Liability |
|
|
|
|
||||||||||
(In thousands) |
|
September 2022 Series B Warrants |
|
|
November 2022 |
|
|
April 2023 |
|
|
Total |
|
||||
Balance, December 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Change in the fair value of liability |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Balance, March 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the activity in the warrant liabilities measured at fair value on a recurring basis using unobservable inputs (Level 3) during the three months ended March 31, 2024:
|
|
Warrant Liability |
|
|||||||||
(In thousands) |
|
September 2022 |
|
|
September 2022 |
|
|
Total |
|
|||
Balance, December 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Change in the fair value of liability |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Assumptions Used in Determining Fair Value of Liability-Classified Warrants
The fair value of the warrant liabilities is based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The fair value of the liability classified warrants (each defined below) were determined using the Black-Scholes Option Pricing Model, which uses various assumptions, including (i) fair value of the Company’s ADSs, (ii) exercise price of the warrant, (iii) expected term of the warrant, (iv) expected volatility and (v) expected risk-free interest rate.
10
Below are the assumptions used for the fair value calculations of the liability classified warrants as of March 31, 2025 and December 31, 2024:
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
||||||||||||||||||
|
|
September 2022 Series B Warrants |
|
|
November 2022 |
|
|
April 2023 |
|
|
September 2022 Series B Warrants |
|
|
November 2022 |
|
|
April 2023 |
|
||||||
Stock (ADS) price |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Exercise price |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Expected term (in years) |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Expected volatility |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||||
Risk-free interest rate |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||||
Expected dividend yield |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Note 5. Accrued Expenses
Accrued expenses consisted of the following as of March 31, 2025 and December 31, 2024 (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Employee compensation and benefits |
|
$ |
|
|
$ |
|
||
External research and development expenses |
|
|
|
|
|
|
||
Professional and consulting fees |
|
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|
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|
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Restructuring |
|
|
|
|
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|
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Other |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
Note 6. Convertible Notes and Notes Payable
September 2024 Note Payable
In November 2024, the Company assumed a promissory note issued by Peak Bio in September 2024 in the amount of $
The Company began making monthly payments subsequent to the acquisition of Peak Bio. As of March 31, 2025 and December 31, 2024, the outstanding balance on the September 2024 Note was $
November 2023 Note Payable
In November 2024, the Company assumed a promissory note issued by Peak Bio in November 2023 in the amount of $
As of December 31, 2024, the principal balance of $
11
The Company recognized interest expense of $
April 2023 Convertible Notes
In November 2024, the Company assumed convertible promissory notes issued by Peak Bio in April 2023 in the principal amount of a total of $
As of March 31, 2025 and December 31, 2024, accrued interest on the April 2023 Notes of less than $
Refer to Note 12 for notes payable, related party and convertible notes, related party.
12
Note 7. Shareholders’ Equity (Deficit)
Ordinary Shares
As of March 31, 2025 and December 31, 2024, the Company was authorized to issue up to
Currently, each ADS represents
March 2025 Private Placement
In March 2025, the Company entered into a securities purchase agreement (the “March 2025 Purchase Agreement”) with certain investors, including the Company’s Chairman, Dr. Hoyoung Huh, director, then President and Chief Executive Officer, Dr. Samir R. Patel, and all other members of the Company’s board, pursuant to which the Company agreed to sell and issue in a private placement (the “March 2025 Offering”) an aggregate of
As part of the March 2025 Offering, Dr. Huh agreed to purchase $
The gross proceeds from the March 2025 Offering were approximately $
The placement agent will be paid three percent (
Merger with Peak Bio, Inc.
On November 14, 2024, the Company completed its previously announced strategic combination with Peak Bio. In connection with the acquisition, the Company issued
The Company determined that the November 2022 Peak Warrants and the April 2023 Peak Warrants are not indexed to the Company’s own stock in the manner contemplated by the relevant accounting standard. Accordingly, on the Closing of the acquisition, the Company classified these warrants as derivative liabilities in its unaudited condensed consolidated balance sheets.
13
Warrants
In connection with various previous financing transactions, the Company has issued warrants to purchase the Company’s ordinary shares represented by ADSs. The Company accounts for such warrants as equity instruments or liabilities, depending on the specific terms of the warrant agreement.
The following table summarizes the Company’s outstanding warrants as of March 31, 2025 and December 31, 2024:
|
|
Number of Warrant ADSs |
|
|
|
|
|
|
||||||
|
|
March 31, |
|
|
December 31, |
|
|
Weighted-Average |
|
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|
|||
|
|
2025 |
|
|
2024 |
|
|
Exercise Price |
|
|
Expiration Date |
|||
Equity-classified Warrants |
|
|
|
|
|
|
|
|
|
|
|
|||
October 2023 Investor Prefunded |
|
|
|
|
|
|
|
$ |
|
|
None |
|||
March 2025 Series A Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
3/6/2026 |
|||
March 2030 Series B Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
3/6/2030 |
|||
May 2024 Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
May-Jun 2027 |
|||
March 2024 Placement Agent Warrants |
|
|
|
|
|
|
|
$ |
|
|
3/27/2029 |
|||
May 2024 Placement Agent Warrants |
|
|
|
|
|
|
|
$ |
|
|
5/31/2029 |
|||
November 2024 Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
Dec 2027-Jun 2028 |
|||
October 2023 Placement Agent Warrants |
|
|
|
|
|
|
|
$ |
|
|
10/6/2028 |
|||
March 2022 Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
3/10/2027 |
|||
March 2022 Placement Agent Warrants |
|
|
|
|
|
|
|
$ |
|
|
3/10/2027 |
|||
December 2021 Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
1/4/2027 |
|||
December 2021 Placement Agent |
|
|
|
|
|
|
|
$ |
|
|
12/29/2026 |
|||
2020 Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
Feb-Mar 2025 |
|||
July 2021 Placement Agent Warrants |
|
|
|
|
|
|
|
$ |
|
|
7/7/2026 |
|||
2020 Placement Warrants |
|
|
|
|
|
|
|
$ |
|
|
Feb-Mar 2025 |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
Liability-classified Warrants |
|
|
|
|
|
|
|
|
|
|
|
|||
April 2023 Peak Bio Warrants |
|
|
|
|
|
|
|
$ |
|
|
4/28/2028 |
|||
September 2022 Series B Investor Warrants |
|
|
|
|
|
|
|
$ |
|
|
9/14/2029 |
|||
November 2022 Peak Bio Warrants |
|
|
|
|
|
|
|
$ |
|
|
11/1/2027 |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
Total outstanding warrants |
|
|
|
|
|
|
|
|
|
|
|
|||
14
The following table summarizes the Company’s warrants activity for the three months ended March 31, 2025:
|
|
Number of |
|
|
Weighted-Average |
|
||
|
|
Warrants |
|
|
Exercise Price |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Issued |
|
|
|
|
|
|
||
Exercised |
|
|
|
|
|
|
||
Expired |
|
|
( |
) |
|
|
|
|
Outstanding at March 31, 2025 |
|
|
|
|
$ |
|
||
Note 8. Stock-Based Compensation
Stock Options
The following is a summary of the Company’s stock option activity under the 2014 Equity Incentive Plan, 2023 Equity Incentive Plan and the Peak Bio 2022 Long Term Incentive Plan for the three months ended March 31, 2025:
|
|
Stock |
|
|
Weighted- |
|
|
Weighted-Average |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
Granted |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|||
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Outstanding at March 31, 2025 (1) |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|||
Exercisable at March 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
___________
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the Company’s ADSs for those options that had exercise prices lower than the fair value of the Company’s ordinary shares.
The weighted-average grant-date fair value per share of options granted during each of the three months ended March 31, 2025 and 2024 was less than $
Option Valuation
The weighted-average assumptions that the Company used to determine the fair value of share options granted were as follows, presented on a weighted average basis:
|
|
2025 |
|
|
2024 |
|
||
Expected volatility |
|
|
% |
|
|
— |
|
|
Risk-free interest rate |
|
|
% |
|
|
— |
|
|
Expected dividend yield |
|
|
— |
|
|
|
— |
|
Expected term (in years) |
|
|
|
|
|
— |
|
|
15
Restricted Stock Units
The 2014 Plan provided, and the 2023 Plan provides, for the award of RSUs. RSUs are granted to employees that are subject to time-based vesting conditions that lapse between
The Company had
As of March 31, 2025, there were
Performance-Based Stock Options
During the first quarter of 2025, the Company granted stock option awards exercisable to purchase
Stock-Based Compensation Expense
The Company classifies stock-based compensation expense in the statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.
|
|
Three Months Ended March 31, |
|
|||||
($ in thousands) |
|
2025 |
|
|
2024 |
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
||
As of March 31, 2025, total unrecognized compensation cost related to unvested stock options was $
Note 9. Net Loss per Share
The following potential dilutive securities, presented based on amounts outstanding at the end of each reporting period, have been excluded from the calculation of diluted net loss per share because including them would have had an anti-dilutive impact:
16
|
|
Three Months Ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Stock options |
|
|
|
|
|
|
||
Restricted stock units |
|
|
|
|
|
|
||
Warrants |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Note 10. Income Taxes
In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes, the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three months ended March 31, 2025 and 2024, the Company recorded
Note 11. Segment Information
The Company manages its operations as a operating segment for the purpose of assessing performance, making operating decisions and allocating resources, resulting in a reportable segment. The Company has determined that its Chief Operating Decision Maker (“CODM”) is its . The Company’s CODM reviews the Company’s financial information on a consolidated basis for the purpose of allocating resources and assessing financial performance.
The Company has assembled a portfolio of preclinical product candidates that aim to develop next-generation precision bifunctional ADCs for the treatment of cancer. The Company has not generated any revenue since its inception and does not expect to generate any revenue from the sale of products in the near future. The Company primarily incurs expenses in connection with the research and development of its product candidates as well as general and administrative costs consisting of salaries and related costs for personnel in executive, finance and administrative functions, as well as consulting, restructuring and merger-related expenses.
|
|
Three Months Ended March 31, |
|
|||||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
HSCT-TMA (AK901) clinical program expense |
|
$ |
( |
) |
|
$ |
( |
) |
ADC preclinical development |
|
|
( |
) |
|
|
— |
|
Chemistry, manufacturing and control |
|
|
( |
) |
|
|
( |
) |
Other external development expense |
|
|
( |
) |
|
|
( |
) |
Internal and other research and development expense |
|
|
( |
) |
|
|
( |
) |
General and administrative expense |
|
|
( |
) |
|
|
( |
) |
Stock-based compensation expense |
|
|
( |
) |
|
|
( |
) |
Other segment items (1) |
|
|
( |
) |
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
||
17
(1)
Assets regularly provided to the CODM are consistent with those reported on the consolidated balance sheets with particular emphasis on the Company’s available liquidity, including its cash and restricted cash. All of the Company’s tangible assets are held in the United States.
Note 12. Related Party Transactions
CEO Agreement
On May 31, 2024, the Company and Dr. Samir Patel entered into an Interim Chief Executive Officer Agreement, effective as of May 1, 2024 (the “Interim CEO Agreement”). Pursuant to the Interim CEO Agreement, Dr. Patel served as the Company’s Interim President and Chief Executive Officer as an independent contractor on an at-will basis. The Interim CEO Agreement could be terminated by the Company immediately for any reason. As the sole compensation for services provided under the Interim CEO Agreement, Dr. Patel was paid $
On December 12, 2024, the Company's board of directors approved the appointment of Dr. Samir Patel to President and Chief Executive Officer, effective December 16, 2024. There were no changes to Dr. Patel's revised compensation under the CEO Amendment Agreement described above, following Dr. Patel's appointment as President and Chief Executive Officer on December 16, 2024.
During the three months ended March 31, 2025, the Company recognized less than $
Notes Payable, Related Party
Pursuant to the acquisition of Peak Bio, which closed on November 14, 2024, the Company assumed
2021 Notes
As a result of the acquisition of Peak Bio, the Company assumed notes in the amount of a total of $
In connection with the March 2025 Private Placement (Note 7), Dr. Huh's 2021 Notes including accrued interest, and a portion of his January 2024 Note (see below), aggregating to $
As of March 31, 2025 and December 31, 2024, the outstanding principal and accrued interest on the 2021 Notes was $
18
January 2024 Note
As a result of the acquisition of Peak Bio, the Company assumed a note in the amount of $
In connection with the March 2025 Private Placement (Note 7), a portion of Dr. Huh’s January 2024 Note and his 2021 Notes aggregating to $
The Company recognized interest expense of less than $
As of March 31, 2025 and December 31, 2024, the outstanding principal balance on the January 2024 Note was $
Convertible Notes, Related Party
On May 10, 2024, the Company entered into unsecured convertible promissory notes (the “May 2024 Notes”) with Dr. Ray Prudo, the Company's Chairman at the time, and its then Interim President and Chief Executive Officer and director, Dr. Samir Patel, for an aggregate of $
The Company recognized
The Doctors Laboratory
The Company leases office space for its U.K. headquarters in London from The Doctors Laboratory (“TDL”) and has incurred expenses of less than $
The Company received certain administrative services provided by DTL, including certain laboratory testing services for its clinical trials, and incurred expenses of less than $
The Company recorded payable balances owed to TDL of less than $
Other
19
In November 2024, the Company assumed an amount due to an entity in which the Company’s Chairman, Dr. Hoyoung Huh, is a director. As of March 31, 2025 and December 31, 2024, the amounts due totaled less than $
Note 13. Commitments and Contingencies
Leases
The Company currently leases office space for both our U.K. and U.S. headquarters on a short-term basis. The lease for our U.K. headquarters, located in London, expires in July 2025, unless terminated earlier with not less than three months notice. The Company leases its U.S. headquarters virtual office, located in Boston, Massachusetts, on a month-to-month basis. The Company also leases laboratory space, located in San Francisco, California, which expires in September 2025 and is cancellable anytime with 60 days’ notice. The Company is not party to any material lease agreements.
For each of the three months ended March 31, 2025 and 2024, the Company incurred lease costs of less than $
Employee Benefit Plans
The Company adopted an employee benefit plan under Section 401(k) of the Internal Revenue Code for its U.S.-based employees. The plan allows employees to make contributions up to a specified percentage of their compensation.
During each of the three months ended March 31, 2025 and 2024, the Company charged less than $
Bayer Acquisition Agreement
In November 2024, the Company assumed an assignment, license, development and commercialization agreement dated March 17, 2017 with Bayer (the “Bayer Acquisition Agreement”), to acquire from Bayer all right, title and interest in and to PHP-303, including each and every invention and any priority rights relating to its patents.
Under the Bayer Acquisition Agreement, the Company is committed to pay certain development and regulatory milestones up to an aggregate amount of $
Either party may terminate the Bayer Acquisition Agreement upon prior written notice for the other party’s material breach that remains uncured for a specified period of time or insolvency. Bayer agreed not to assert any Bayer intellectual property rights that were included in the scope of the Bayer Acquisition Agreement against the Company.
The Company incurred
Legal Proceedings
20
In December 2024, the Company received demand letters from two individuals formerly serving the Company as consultants outlining claims relating to wrongful termination. The wrongful termination claims included claims for unpaid consulting fees, consulting fees owed due to improper termination notice, unpaid bonuses, severance, and the accelerated vesting of outstanding restricted stock unit awards as of the termination date. On March 3, 2025, the Company signed a Settlement Agreement and Mutual Release with one of its former consultants. The agreement requires the Company to make a payment in the amount of $
On November 21, 2024, “Sabby” Volatility Warrant Master Fund Ltd. (“Sabby”) filed a lawsuit against the Company in New York state court for alleged breach of contract. Sabby alleges that it validly exercised a warrant issued to Sabby in September 2022 and alleges that the Company breached the warrant by not honoring Sabby's exercise request. On May 7, 2025, the Company and Sabby entered into a Settlement Agreement pursuant to which the Company will issue ADSs to Sabby at a future date equivalent to the agreed settlement amount, which has been accrued as of March 31, 2025.
Note 14. Restructuring
In May 2024, the Company implemented a reduction-in-force of approximately
The following table presents the restructuring reserve and accrual activity for the three months ended March 31, 2025:
|
|
Severance and |
|
|
Other |
|
|
|
|
|||
(In thousands) |
|
Employee Benefit Costs |
|
|
Restructuring Charges |
|
|
Total |
|
|||
Balance at December 31, 2024 |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Cash payments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Balance at March 31, 2025 |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|||
The restructuring reserve is presented within “accrued expenses” in the Company’s condensed consolidated balance sheets.
Note 15. Subsequent Events
Appointment of New President and Chief Executive Officer
On March 14, 2025, the Company entered into an Executive Offer of Employment Agreement (as amended by a subsequent Chief Executive Officer Letter Agreement, dated March 18, 2025, the “Employment Agreement”) with Mr. Abizer Gaslightwala pursuant to which Mr. Gaslightwala will serve as the President and Chief Executive Officer of the Company, effective on April 21, 2025. Mr. Gaslightwala will earn a base salary, which includes an
21
annual cash bonus target, and receive share-based payment compensation based on time service and the achievement of specific performance criteria.
Funds Received from March 2025 Private Placement
In April 2025, the Company received the remaining cash proceeds of $
22
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with:
In addition to historical information, this discussion and analysis contains forward-looking statements that are subject to risks and uncertainties, including those discussed in the section titled “Risk Factors,” set forth in Item 1A of our Form 10-K, that could cause actual results to differ materially from historical results or anticipated results.
Overview
We are an oncology company developing next-generation antibody-drug conjugates (“ADCs”) designed around novel proprietary cancer-killing toxins (“payloads”). We believe these novel payloads may have the potential to transform the efficacy and safety outcomes of ADCs as cancer therapies beyond options that are currently available or in development.
ADCs are a class of cancer therapies that combine the precision targeting of antibodies with payload toxins that attack cancer cells. To date, innovation in the field of ADC therapies has focused primarily on the development of novel antibodies linked to existing classes of payload toxins. For example, there is a range of approved ADCs with antibodies that target the Her2, Trop2, CD19, CD22, CD30, Nectin-4, Tissue Factor, and FR alpha antibodies. But there is a surprising lack of diversity in the payload toxins to which those antibodies are linked, as all of these marketed products, and more than 90% of ADCs in late-stage clinical development of which we are aware, utilize payloads from just two standard classes: (1) microtubule inhibitors or (2) DNA-damaging agents such as topoisomerase I inhibitors.
Our differentiated ADC discovery and development platform (our “ADC Platform”) enables us to generate a range of ADC product candidates that pair our novel payloads with biologically validated antibody targets prevalent in cancer tumors. We believe that our focus on the development of ADCs that utilize our novel payloads may allow us to develop ADCs with benefits that include:
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.
We acquired the ADC Platform in connection with the acquisition of Peak Bio (the “Merger”). Prior to that time, we
23
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.
Our activities since inception have consisted of performing research and development activities and raising capital.
We do not have any products available for commercial sale, and we have not generated any product revenue from our portfolio of product candidates or other sources. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the successful development and eventual commercialization of our potential therapies, which we expect, if it ever occurs, will take a number of years. The research and development efforts require significant amounts of additional capital and adequate personnel infrastructure. There can be no assurance that our research and development activities will be successfully completed, or that our potential therapies will be commercially viable.
Recent Developments
Appointment of New President and Chief Executive Officer
On March 14, 2025, we entered into an Executive Offer of Employment Agreement (as amended by a subsequent Chief Executive Officer Letter Agreement, 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.
March 2025 Private Placement
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”).
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.
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.
24
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).
Pipeline Prioritization of the Merged Companies
In May 2024, we announced the completion of a joint portfolio prioritization review pursuant to which the anticipated combined entity, following completion of the proposed Merger (as defined below), will focus on Peak Bio’s ADC platform technology. As a result, our 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.
Restructuring and Reduction-in-Force
In May 2024, we implemented a reduction-in-force (the “RIF”) of approximately 67% of our total workforce, as a result of the 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.
Merger Agreement
On November 14, 2024, we completed the previously announced business combination contemplated by the Merger Agreement with Peak Bio, pursuant to which, upon the terms and subject to the conditions thereof, Merger Sub was merged with and into Peak Bio, with Peak Bio surviving such merger as our wholly owned subsidiary.
For additional information on the Merger, refer to our Form 10-K for the fiscal year ended December 31, 2024.
25
Results of Operations
Three Months Ended March 31, 2025 and 2024
Overview
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 $6.0 million for the three months ended March 31, 2024. General and administrative expenses comprise the majority of our total operating expenses, as shown in the table below:
|
|
Three Months Ended |
|
|
|
|
|
|
|
|||||||
|
|
March 31, |
|
|
Change |
|
||||||||||
($ in thousands) |
|
2025 |
|
|
2024 |
|
|
$ |
|
|
% |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
813 |
|
|
$ |
2,279 |
|
|
$ |
(1,466 |
) |
|
|
-64 |
% |
General and administrative |
|
|
2,712 |
|
|
|
3,710 |
|
|
|
(998 |
) |
|
|
-27 |
% |
Total operating expenses |
|
|
3,525 |
|
|
|
5,989 |
|
|
|
(2,464 |
) |
|
|
-41 |
% |
Loss from operations |
|
$ |
(3,525 |
) |
|
$ |
(5,989 |
) |
|
$ |
2,464 |
|
|
|
-41 |
% |
Research and development expenses
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.
During the three months ended March 31, 2025, total research and development expenses decreased by approximately $1.5 million, or 64%, as compared to the three months ended March 31, 2024. The following sets forth research and development expenses for the three months ended March 31, 2025 and 2024 by category:
|
|
Three Months Ended |
|
|
|
|
|
|
|
|||||||
|
|
March 31, |
|
|
Change |
|
||||||||||
($ in thousands) |
|
2025 |
|
|
2024 |
|
|
$ |
|
|
% |
|
||||
Clinical Trials: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
HSCT-TMA clinical development (AK901) |
|
$ |
62 |
|
|
$ |
633 |
|
|
$ |
(571 |
) |
|
|
-90 |
% |
ADC preclinical development |
|
|
17 |
|
|
|
— |
|
|
|
17 |
|
|
|
100 |
% |
Chemistry, manufacturing and control |
|
|
28 |
|
|
|
711 |
|
|
|
(683 |
) |
|
|
-96 |
% |
Other external development expenses |
|
|
98 |
|
|
|
305 |
|
|
|
(207 |
) |
|
|
-68 |
% |
Personnel costs |
|
|
608 |
|
|
|
630 |
|
|
|
(22 |
) |
|
|
-3 |
% |
Total research and development expenses |
|
$ |
813 |
|
|
$ |
2,279 |
|
|
$ |
(1,466 |
) |
|
|
-64 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
HSCT-TMA clinical development (AK901)
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.
ADC preclinical development
26
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.
Chemistry, manufacturing and control
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.
Other external development expenses
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.
Personnel costs
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.
The extent of our future research and development expenditures will be determined based on future funding.
General and administrative expenses
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.
Interest income
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.
Interest expense
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.
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.
27
Gain on Debt Extinguishment
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.
Change in fair value of warrant liabilities
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.
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.
Foreign currency exchange gain, net
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.
Other expense, net
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.
28
Net Loss Applicable to Common Shareholders
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.
29
Financial Condition, Liquidity and Capital Resources
Sources of Liquidity
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.
We have devoted substantially all of our efforts to research and development, including clinical trials, and we have not commercialized any products. Our research and development activities, together with our general and administrative expenses, are expected to continue to result in substantial operating losses for the foreseeable future. These losses, among other things, have had and will continue to have an adverse effect on our shareholders’ equity, total assets and working capital. Due to the numerous risks and uncertainties associated with developing drug candidates and, if approved, commercial products, we are unable to predict the extent of any future losses, whether or when any of our drug candidates will become commercially available or when we will become profitable, if at all. Our future capital requirements will depend on many factors, including:
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
30
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.
March 2025 Private Placement
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.”
November 2024 Private Placement
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.
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.
May 2024 Private Placement
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.
May 2024 Convertible Notes
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.
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.
March 2024 Private Placement
31
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.
Funding Requirements
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.
Financing may not be available to us when we need it, or on favorable or acceptable terms, or at all. We could be required to seek funds through means that may require us to relinquish rights to some of our technologies, drug candidates or drugs that we would otherwise pursue on our own. In addition, if we raise additional funds by issuing equity securities, our then existing shareholders may experience dilution. The terms of any financing may adversely affect the holdings or the rights of existing shareholders. An equity financing that involves existing shareholders may cause a concentration of ownership. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, and are likely to include rights that are senior to the holders of our ordinary shares. Any additional debt or equity financing may contain terms which are not favorable to us or to our shareholders, such as liquidation and other preferences, or liens or other restrictions on our assets. As discussed in Note 11 to the consolidated financial statements included in the 2024 Form 10-K, additional equity financings may also result in cumulative changes in ownership over a three-year period in excess of 50% which would limit the amount of net operating loss and tax credit carryforwards that we may utilize in any one year.
If we are unable to raise additional capital when required or on acceptable terms, we may be required to:
Any of these events could have a material adverse effect on our business, operating results, and prospects.
We believe the key factors which will affect our ability to obtain funding are:
32
anticipated benefits of the Merger;
In addition, increases in expenses or delays in clinical development may adversely impact our cash position and require additional funds or cost reductions.
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.
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Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
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Three Months Ended |
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March 31, |
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(In thousands) |
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2025 |
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2024 |
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||
Net cash (used in) provided by: |
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||
Net cash used in operating activities |
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$ |
(2,150 |
) |
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$ |
(4,044 |
) |
Net cash provided by financing activities |
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2,133 |
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|
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1,514 |
|
Effect of exchange rates on cash |
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— |
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(5 |
) |
Net change in cash |
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$ |
(17 |
) |
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$ |
(2,535 |
) |
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.
Investment Activities. There were no investing activities during the three months ended March 31, 2025 and 2024.
Financing Activities. Net cash provided by financing activities primarily consisted of the following:
Material Cash Requirements
Insurance Financing Obligations
In January 2025, we entered into a short-term financing arrangement with a third-party vendor to finance insurance premiums. The aggregate amount financed under this agreement was $0.5 million which is scheduled to be paid in monthly installments through November 2025.
Debt Obligations
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 March 31, 2025, these obligations are expected to result in principal payments of approximately $1.6 million.
Other
We enter into a variety of agreements and financial commitments in the normal course of business. The terms generally provide us the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. However, it is not possible to predict the amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.
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Critical Accounting Estimates
This management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. In doing so, we must make estimates and assumptions that affect our reported amounts of assets, liabilities and expenses, as well as related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates and judgments, including, but not limited to, those related to (i) stock-based compensation, (ii) fair value of warrants classified as liabilities, (iii) research and development prepayments, accruals and related expenses, (iv) income taxes, and (v) intangible assets impairment. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We regard an accounting estimate or assumption underlying our financial statements as a “critical accounting estimate” if:
There have been no material changes to our critical accounting policies and estimates since December 31, 2024. See ”Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates” of our Form 10-K, for a discussion of significant estimates and assumptions made by our management as part of the preparation of this management's discussion and analysis of financial condition and results of operations and accompanying condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required under this item.
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Item 4. Controls and Procedures.
As previously disclosed under “Part II - Item 9A - Controls and Procedures” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, management concluded that our internal control over financial reporting was not effective at the reasonable assurance level as of December 31, 2024, due to certain deficiencies that constituted material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
We have not yet begun to engage in the implementation of remediation efforts to address the material weaknesses, as well as other identified areas of risk. For a complete description of management’s remediation plan, see “Part II - Item 9A - Controls and Procedures” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) as of March 31, 2025. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applied its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, and previously identified material weaknesses in internal control over financial reporting, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective at a reasonable assurance level as of March 31, 2025.
Management’s Implementation of Remediation Plan
Management, with oversight from the Audit Committee, has not yet commenced implementing changes to our internal control over financial reporting in order to remediate the control deficiencies that resulted in the material weaknesses as previously disclosed in our Form 10-K for the fiscal year ended December 31, 2024. We expect to begin our efforts during the third quarter and continue our efforts through fiscal year 2025 to remediate the material weaknesses described in our Form 10-K for the fiscal year ended December 31, 2024. We believe that the remediation steps disclosed under “Part II - Item 9A - Controls and Procedures” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 will allow us to address the deficient controls within our internal control environment, which will facilitate the remediation of the material weaknesses.
Given that remediation efforts described in our Form 10-K have not commenced, we will not be able to consider the material weaknesses remediated until the applicable remedial controls operate for a sufficient period of time and our management has concluded, through testing, that our controls are operating effectively. We, along with our Audit Committee, will continue to monitor and evaluate the effectiveness of these remedial actions and take further actions as deemed appropriate.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the fiscal quarter ended March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation relating to claims arising out of operations in the normal course of business, which we consider routine and incidental to our business.
Refer to Note 13 of the Notes to our condensed consolidated financial statements related to commitments and contingencies, which is incorporated herein by reference.
Item 1A. Risk Factors.
Investing in our securities involves a high degree of risk. You should carefully consider the risks and uncertainties discussed within “Item 1A. Risk Factors” of our Form 10-K, together with all of the other information in this Form 10-Q, including the section “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and related notes, before deciding whether to purchase any of our ADSs.
There have been no material changes to the risk factors from those previously disclosed in our Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the three months ended March 31, 2025, we did not have any sales of unregistered securities, other than as previously disclosed by us in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
Item 5. Other Information.
None of our directors or “officers,” as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934,
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Item 6. Exhibits.
Exhibit Number |
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Description |
2.1 |
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10.1 |
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10.2 |
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10.3 |
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10.4 |
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10.5*† |
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10.6†
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31.1* |
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31.2* |
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32.1** |
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32.2** |
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101.INS |
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Inline XBRL Instance Document–the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
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lnline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents. |
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* Filed herewith.
** This certification is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except to the extent that the Registrant specifically incorporates it by reference.
† Indicates management contract or compensatory arrangement.
38
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Akari Therapeutics, Plc |
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By: |
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Date: May 14, 2025 |
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/s/ Abizer Gaslightwala |
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Abizer Gaslightwala |
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President and Chief Executive Officer |
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By: |
/s/ Torsten Hombeck, Ph.D. |
Date: May 14, 2025 |
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Torsten Hombeck, Ph.D. |
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Chief Financial Officer |
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39
March 13, 2025
Abizer Gaslightwala
Re: Offer of Employment by Akari Therapeutics, Plc
Dear Abizer:
On behalf of Akari Therapeutics, Plc (the “Company”), I am pleased to confirm our offer to employ you as Chief Executive Officer. The initial terms and conditions of your employment, should you accept this offer, are set forth below in this letter agreement (the “Agreement”):
To the extent applicable, you shall be deemed to have resigned from all officer and board member positions that you hold with the Company or any of its respective subsidiaries and affiliates upon the termination of your employment for any reason. You shall execute any documents as may be requested to confirm or effectuate any such resignations.
If your employment ends for any reason other than a termination by the Company without Cause, you will be entitled to the Accrued Obligations and will not be entitled to any further compensation from the Company. For the avoidance of doubt, if your employment ends due to your death or disability, you will receive the Accrued Obligations but will not be eligible for severance pay and benefits, whether pursuant to Section 8, Section 9 or otherwise.
For the avoidance of doubt, Section 9 and Section 10 of this Agreement are mutually exclusive and in no event shall you be entitled to payments or benefits pursuant to both Section 9 and Section 10 of this Agreement.
(a) Non-Competition and Non-Solicitation You understand that the nature of your position gives you access to and knowledge of Confidential Information and places you in a position of trust and confidence with the Company. You further understand and acknowledge that the Company's ability to reserve these for the exclusive knowledge and use of the Company is of great competitive importance and commercial value to the Company, and that improper use or disclosure by you is likely to result in unfair or unlawful competitive activity.
Agreement may be amended, as reasonably requested by either party, and as may be necessary to fully comply with Section 409A of the Code and all related rules and regulations in order to preserve the payments and benefits provided hereunder without additional cost to either party.
EACH PARTY HERETO IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY DISPUTE DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS LETTER AND ANY OF THE AGREEMENTS DELIVERED IN CONNECTION HEREWITH.
Each party hereto certifies and acknowledges that (i) no representative, agent or attorney of any other party hereto has represented, expressly or otherwise, that such other party would not, in the event of litigation or arbitration, seek to enforce such waivers, (ii) it understands and has considered the implications of such waivers, (iii) it makes such waivers voluntarily, and (iv) it has been induced to enter into this Letter by, among other things, the mutual waivers and certifications in this Section 13.
this Agreement without your consent to any affiliate or to any person or entity with whom the Company shall hereafter effect a reorganization, consolidate with, or merge into or to whom it transfers all or substantially all of its properties or assets; provided further, that if you remain employed or become employed by the Company, the purchaser or any of their affiliates in connection with any such transaction, then you shall not be entitled to any payments, benefits or vesting pursuant to Section 8 or pursuant to Section 9 of this Agreement solely as a result of such transaction. This Agreement shall inure to the benefit of and be binding upon you and the Company, and each of your and its respective successors, executors, administrators, heirs and permitted assigns.
[Signature page follows.]
To accept this offer of employment, please sign and return this Agreement and the Restrictive Covenants Agreement to me at Hoyoung.Huh@akaritx.com by March 17, 2025. We look forward to your joining the Company.
By: /s/ Hoyoung Huh
Name: Dr. Hoyoung Huh
Title: Chairman of the Board
I have read and accept this employment offer:
By: /s/ Abizer Gaslightwala
Name: Abizer Gaslightwala
Date: March 14, 2025
Appendix A
Exhibit 31.1
CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER UNDER
SECTION 302 OF THE SARBANES-OXLEY ACT
I, Abizer Gaslightwala, certify that:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the company's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
Date: May 14, 2025
/s/ Abizer Gaslightwala |
Abizer Gaslightwala |
President and Chief Executive Officer |
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER UNDER
SECTION 302 OF THE SARBANES-OXLEY ACT
I, Torsten Hombeck, certify that:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the company's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
Date: May 14, 2025
/s/ Torsten Hombeck, Ph.D. |
Torsten Hombeck, Ph.D. |
Chief Financial Officer |
(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Akari Therapeutics, Plc (the “Company”) on Form 10-Q for the quarter ended March 31, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s knowledge:
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Date: May 14, 2025 |
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/s/ Abizer Gaslightwala |
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Abizer Gaslightwala |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Akari Therapeutics, Plc (the “Company”) on Form 10-Q for the quarter ended March 31, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s knowledge:
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Date: May 14, 2025 |
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/s/ Torsten Hombeck, Ph.D. |
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Torsten Hombeck, Ph.D. |
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Chief Financial Officer |
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(Principal Financial Officer) |
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