UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On January 16, 2024, Allakos Inc. (the “Company”) issued a press release announcing its estimated, unaudited cash, cash equivalents and investments balance as of December 31, 2023, which it expects will fund operations into mid-2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 2.05 Costs Associated with Exit or Disposal Activities.
On January 16, 2024, the Company announced plans to halt development of lirentelimab, the Company’s former lead product candidate, and focus on the clinical development of its AK006 program. As part of the corporate restructuring, the Company is halting lirentelimab-related activities across clinical, manufacturing, research and administrative functions. The Company also committed to reducing its workforce by approximately 50%.
The total costs related to halting lirentelimab-related activities and reducing the workforce are estimated to be approximately $30 million, with the majority of these amounts expected to be paid in the first half of 2024. Approximately $24 million will be incurred in connection with halting lirentelimab-related activities and the remaining approximately $6 million will be incurred in connection with the workforce reduction. These estimates are subject to a number of assumptions and actual results may differ. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the corporate restructuring.
A copy of the press release announcing the corporate restructuring is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure.
On January 16, 2024, the Company issued a press release announcing its Phase 2 clinical trial of subcutaneous lirentelimab in patients with atopic dermatitis and its Phase 2b clinical trial of subcutaneous lirentelimab in patients with chronic spontaneous urticaria both did not achieve statistical significance on the primary endpoints. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.
All of the information in this Item 7.01 and Items 2.02 and 9.01 of this Form 8-K, including the attached Exhibit 99.1 and Exhibit 99.2, is intended to be furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.
Forward Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements are identified by such words as “expect,” “anticipate,” “estimate” and words of similar import and are based on current expectations. All statements other than historical or current facts are forward-looking statements, including, without limitation, statements about the nature, timing and scope of the corporate restructuring, including the expected costs of such restructuring and expected timing of the payment of such costs, the Company’s estimate of unaudited cash, cash equivalents and investments as of December 31, 2023, and the Company’s cash runway. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including but not limited to, delays in the implementation of the Company’s plans, unexpected restructuring or personnel-related termination or other costs, and the Company’s ability to accurately forecast financial results. A further description of the risks and uncertainties relating to the business of the Company is contained in the section entitled “Risk Factors” in documents that the Company files from time to time with the SEC. The forward-looking statements in this report speak only as of the date hereof. Except as required by law, the Company does not undertake to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date hereof.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
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99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Allakos Inc. |
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Date: |
January 16, 2024 |
By: |
/s/ H. Baird Radford, III |
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H. Baird Radford, III |