0001564824falseNONE00015648242024-08-072024-08-07

 

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): August 07, 2024

 

 

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

 

Not Applicable

(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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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.

 


Item 2.02 Results of Operations and Financial Condition.

On August 7, 2024, Allakos Inc. (the “Company”) issued a press release reporting its financial results for the second quarter ended June 30, 2024. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 2.02 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, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

Description

 99.1

Press Release dated August 7, 2024.

 

 

 

104

 

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 thereunto duly authorized.

 

 

 

Allakos Inc.

 

 

 

 

Date:

August 7, 2024

By:

/s/ H. Baird Radford, III

 

 

 

H. Baird Radford, III
Chief Financial Officer

 


Exhibit 99.1

 

Allakos Provides Business Update and Reports Second Quarter 2024 Financial Results

 

SAN CARLOS, Calif., August 7, 2024 (GLOBE NEWSWIRE) – Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today provided a business update and reported financial results for the second quarter ended June 30, 2024.

Recent Allakos Events

Initiated the randomized, double-blind, placebo-controlled Phase 1 trial of intravenous (IV) AK006 in patients with chronic spontaneous urticaria.
Completed dosing in the randomized, double-blind, placebo-controlled subcutaneous (SC) AK006 cohort in healthy volunteers.
Reported safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 trial of IV AK006 in healthy volunteers.
Presented preclinical data at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress on mast cell inhibition with AK006.

 

Upcoming Allakos Anticipated Milestones

Report safety, PK, and PD results from the Phase 1 trial of SC AK006 in healthy volunteers in Q3 2024.
Report randomized double-blind, placebo-controlled data from the Phase 1 trial of AK006 in patients with CSU at year end 2024.

 

Cash Guidance

Allakos ended the second quarter of 2024 with $123.1 million in cash, cash equivalents and investments. Allakos’ financial outlook, restructuring activities and estimated cash runway as reported by the Company in January 2024 remain unchanged. The Company reiterates that the restructuring activities will extend the cash runway into mid-2026 and continues to expect to end 2024 with total cash, cash equivalents and investments in the range of $81 to $86 million. The Company reiterates that an estimated $30 million of closeout, severance and other costs will be paid in 2024 in connection with exiting the lirentelimab development program, of which we have spent $13 million to date in the first six months of 2024. Approximately $1 million of these payments were made in the second quarter of 2024.

 

Second Quarter 2024 Financial Results

Allakos ended the second quarter of 2024 with $123.1 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $16.2 million during the second quarter of 2024.

Research and development expenses were $19.4 million in the second quarter of 2024 compared to $27.3 million in the second quarter of 2023, a decrease of $7.9 million. This quarter over quarter decrease is attributed to $2.5 million of lower contract research and development costs, primarily due to halting lirentelimab development, $2.5 million of decreased compensation costs and a $2.9 million decrease in other research and development expenses.


General and administrative expenses were $9.2 million for the second quarter of 2024 compared to $10.5 million for the second quarter of 2023, a decrease of $1.3 million. The quarter over quarter change included $0.7 million of decreased compensation costs and $0.6 million of decreased other general and administrative expenses.

Allakos reported a net loss of $26.7 million in the second quarter of 2024 compared to $35.1 million in the second quarter of 2023. Net loss per basic and diluted share was $0.30 for the second quarter of 2024 compared to $0.41 in the second quarter of 2023.

About Allakos

Allakos is a clinical stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The Company’s most advanced product candidate is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed on mast cells. Mast cells are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. In preclinical studies, AK006 appears to provide deep mast cell inhibition and, in addition to its inhibitory activity, reduce mast cell numbers. For more information, please visit the Company’s website at www.allakos.com.

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’ expected timing of reporting data from its clinical trial of AK006; cash guidance and runway; and restructuring. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ stages of clinical drug development; Allakos’ ability to timely initiate and complete clinical trials for AK006; Allakos’ ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of clinical trials, regardless of the outcomes of preclinical testing or early-stage trials; Allakos’ ability to obtain regulatory approvals to market its product candidates; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos’ ability to advance additional product candidates beyond AK006; uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring and related reduction in force; Allakos’ ability to accurately forecast financial results; Allakos’ ability to obtain additional capital to finance its operations, research and drug development; Allakos’ ability to maintain the listing of our common stock on Nasdaq; general economic and market conditions, both domestic and international; domestic and international regulatory obligations; 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.

 

###

 

Source: Allakos Inc.

 

Investor Contact:

Adam Tomasi, President

Alex Schwartz, VP Strategic Finance and Investor Relations

ir@allakos.com

Media Contact:

Denise Powell

denise@redhousecomms.com

 

 


Allakos Inc.

UNAUDITED Statements of Operations and Comprehensive Loss

(in thousands, except per share data)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

19,422

 

 

$

27,280

 

 

$

54,246

 

 

$

60,358

 

General and administrative

 

 

9,211

 

 

 

10,537

 

 

 

20,109

 

 

 

22,505

 

Impairment of long-lived assets

 

 

 

 

 

 

 

 

27,347

 

 

 

 

Total operating expenses

 

 

28,633

 

 

 

37,817

 

 

 

101,702

 

 

 

82,863

 

Loss from operations

 

 

(28,633

)

 

 

(37,817

)

 

 

(101,702

)

 

 

(82,863

)

Interest income

 

 

1,959

 

 

 

2,697

 

 

 

3,954

 

 

 

5,375

 

Other expense, net

 

 

(2

)

 

 

 

 

 

(74

)

 

 

(36

)

Net loss

 

 

(26,676

)

 

 

(35,120

)

 

 

(97,822

)

 

 

(77,524

)

Unrealized gain (loss) on investments

 

 

(11

)

 

 

(171

)

 

 

(41

)

 

 

125

 

Comprehensive loss

 

$

(26,687

)

 

$

(35,291

)

 

$

(97,863

)

 

$

(77,399

)

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.30

)

 

$

(0.41

)

 

$

(1.11

)

 

$

(0.90

)

Weighted-average number of common
   shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

88,644

 

 

 

86,646

 

 

 

88,342

 

 

 

86,246

 

 

 


allakos inc.

UNAUDITED CONDENSED balance sheets

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,496

 

 

$

66,440

 

Investments

 

 

96,625

 

 

 

104,354

 

Prepaid expenses and other current assets

 

 

4,805

 

 

 

9,095

 

Total current assets

 

 

127,926

 

 

 

179,889

 

Property and equipment, net

 

 

16,590

 

 

 

33,369

 

Operating lease right-of-use assets

 

 

10,228

 

 

 

24,136

 

Other long-term assets

 

 

1,714

 

 

 

6,216

 

Total assets

 

$

156,458

 

 

$

243,610

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

16,119

 

 

$

1,764

 

Accrued expenses and other current liabilities

 

 

19,761

 

 

 

34,814

 

Total current liabilities

 

 

35,880

 

 

 

36,578

 

Operating lease liabilities, net of current portion

 

 

36,579

 

 

 

38,215

 

Total liabilities

 

 

72,459

 

 

 

74,793

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

89

 

 

 

88

 

Additional paid-in capital

 

 

1,300,200

 

 

 

1,287,156

 

Accumulated other comprehensive gain (loss)

 

 

9

 

 

 

50

 

Accumulated deficit

 

 

(1,216,299

)

 

 

(1,118,477

)

Total stockholders’ equity

 

 

83,999

 

 

 

168,817

 

Total liabilities and stockholders’ equity

 

$

156,458

 

 

$

243,610

 

 


v3.24.2.u1
Document And Entity Information
Aug. 07, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 07, 2024
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
Entity Information, Former Legal or Registered Name Not Applicable
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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