ALLK Allakos Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 27, 2025

 

 

Allakos Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-38582	45-4798831
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
825 Industrial Road, Suite 500
San Carlos, California				94070
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 650 597-5002

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001		ALLK		The Nasdaq Global Select Market

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On January 27, 2025, Allakos Inc. (the “Company”) issued a press release announcing its estimated, unaudited cash, cash equivalents, and investments balance as of December 31, 2024. 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 27, 2025, the Company announced plans to discontinue development of AK006. As part of the corporate restructuring, the Company plans to discontinue AK006-related activities across clinical, manufacturing, research and administrative functions. The Company also plans to reduce its workforce by approximately 75%.

 

The total costs related to discontinuing AK006-related activities and reducing the workforce are estimated to be approximately $34 million to $38 million, with a significant majority of these amounts expected to be paid in the first half of 2025. Approximately $24 million to $28 million will be incurred in connection with discontinuing AK006-related activities and the remaining approximately $10 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 27, 2025, the Company issued a press release announcing that its Phase 1 clinical trial of AK006 in patients with chronic spontaneous urticaria (CSU) did not demonstrate therapeutic activity in patients with CSU. The Company also announced that it plans to discontinue development of AK006, reduce its workforce by approximately 75% and explore strategic alternatives. A copy of the press release is attached as Exhibit 99.1 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, 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 estimated costs of such restructuring and expected timing of the payment of such costs, the Company’s plan to explore strategic alternatives, and the Company’s estimate of unaudited cash, cash equivalents and investments as of December 31, 2024. 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, uncertainties related to the Company’s ability to realize the contemplated benefits of its restructuring activities and related reduction in force; the Company’s ability to accurately forecast financial results, including restructuring and other costs and expenses; availability of suitable third parties with which to conduct contemplated strategic alternative transactions; whether the Company will be able to pursue strategic alternative transactions, or whether any transaction, if pursued, will be completed on attractive terms; whether the Company’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; the Company’s ability to maintain the listing of its common stock on Nasdaq; general economic and market conditions, both domestic and international; risks associated with volatility and uncertainty in the capital markets for biotechnology companies; and other risks. A further description of the risks and uncertainties relating to 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.

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Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Press Release dated January 27, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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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.

			Allakos Inc.
Date:	January 27, 2025	By:	/s/ H. Baird Radford, III
			H. Baird Radford, III Chief Financial Officer

 

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Exhibit 99.1

 

Allakos Announces Topline Results from its Phase 1 Trial of AK006 in Patients with Chronic Spontaneous Urticaria and Announces Restructuring

– AK006 did not demonstrate therapeutic activity in CSU –

– Allakos will discontinue further development of AK006, reduce workforce by 75% and explore strategic alternatives –

– Management to host conference call and webcast today at 8:30 am E.T. –

SAN CARLOS, Calif., January 27, 2025 (GLOBE NEWSWIRE) – Allakos Inc. (Company) (Nasdaq: ALLK), today announced topline results from its phase 1 clinical trial of AK006 in chronic spontaneous urticaria (CSU).

“While AK006 was well tolerated, we are disappointed that the preclinical inhibitory effects observed did not translate to clinical benefit in patients with CSU. As a result, the Company has decided to discontinue further clinical development of AK006,” said Chin Lee, M.D, M.P.H., Chief Medical Officer of Allakos. “We express our gratitude to all of the patients, clinical trial investigators, and site coordinators in these trials.”

Phase 1 Cohort of AK006 in Patients with Chronic Spontaneous Urticaria

In the CSU cohort, 34 adult patients with moderate-to-severe CSU refractory to antihistamines with or without prior exposure to omalizumab were enrolled and randomized 2:1 to receive 720 mg of intravenous AK006 (n=23) or placebo (n=11) once every four weeks (Q4W). Eight of the 34 patients had previously received omalizumab (5 randomized to AK006, 3 randomized to placebo). The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score (UAS)-7 at 14 weeks.

Exploratory Efficacy Results

	AK006 (n=23)	Placebo (n=11)
Baseline Urticaria Activity Score (UAS7)	34.4	30.5
Mean Change in UAS7	-8.2	-12.4
% UAS7=0: Complete Response	9% (2/23)	9% (1/11)

Safety Results
 

AK006 was well-tolerated with a favorable safety profile. There were no serious adverse events (SAEs) in subjects on AK006. Adverse events occurring in 2 or more subjects on AK006 were headache (2), infusion related reaction (2), and Covid-19 (2) vs. 1, 0, and 0, respectively, on placebo, all of which were mild-to-moderate in severity.

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Restructuring Activities & Planned Actions

Cash Guidance

The Company ended the fourth quarter of 2024 with approximately $81 million in cash, cash equivalents, and investments (unaudited).

The Company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors, will be approximately $34 million to $38 million. The Company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025.

The Company estimates it will have cash, cash equivalents and investments in a range of approximately $35 million to $40 million at June 30, 2025.

Conference Call and Webcast Information

The webcast and conference call will take place at 8:30 am ET / 5:30 am PT on January 27th, 2025. Please click here (https://register.vevent.com/register/BI233bd44e1a56423c85d5b9afdd587b47) to pre-register to participate in the conference call and obtain your dial in number and PIN.

A webcast of the live call will be available online in the investor relations section of the Allakos website here (https://edge.media-server.com/mmc/p/rrrcxwmj/). Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company’s website for approximately 30 days.

About Allakos

 

Allakos is a clinical stage biotechnology company that has been developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ expectations regarding its financial position and guidance, including estimated costs of restructuring activities to closeout AK006 development, the timing of payment of such restructuring costs, and estimated ending 2024 and second quarter 2025 cash, cash equivalents and investments; restructuring activities and plans; and exploration of strategic alternatives. Such statements are based on Allakos’ current views about its plans, intentions, expectations, strategies

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and prospects only as of the date of this release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from those set forth in or implied by such forward-looking statements, including but not limited to: uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring activities and related reduction in force; Allakos’ ability to accurately forecast financial results, including restructuring and other costs and expenses; availability of suitable third parties with which to conduct contemplated strategic alternative transactions; whether Allakos will be able to pursue strategic alternative transactions, or whether any transaction, if pursued, will be completed on attractive terms; whether Allakos’ cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Allakos’ ability to maintain the listing of its common stock on Nasdaq; general economic and market conditions, both domestic and international; risks associated with volatility and uncertainty in the capital markets for biotechnology companies; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Allakos files from time to time to with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release.

 

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Source: Allakos Inc.

 

Investor Contact:
Adam Tomasi, President
Alex Schwartz, VP Strategic Finance and Investor Relations
ir@allakos.com 

 

Media Contact:
media@allakos.com

 

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v3.24.4

Document And Entity Information	Jan. 27, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 27, 2025
Entity Registrant Name	Allakos Inc.
Entity Central Index Key	0001564824
Entity Emerging Growth Company	false
Entity File Number	001-38582
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-4798831
Entity Address, Address Line One	825 Industrial Road, Suite 500
Entity Address, City or Town	San Carlos
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94070
City Area Code	650
Local Phone Number	597-5002
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	ALLK
Security Exchange Name	NONE

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