8-K
0001564824false00015648242021-11-082021-11-08

 

 

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)

November 8, 2021

 

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.)

 

 

 

 

 

975 Island Drive, Suite 201

Redwood City, California 94065

(Address of principal executive offices, including zip code)

(650) 597-5002

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

 

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

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 (see General Instruction A.2. below):

 

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))

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 November 8, 2021, Allakos Inc. (the “Company”) issued a press release reporting its financial results for the third quarter ended September 30, 2021. 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 November 8, 2021.

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1


 

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 hereunto duly authorized.

 

 

 

Allakos Inc.

 

 

 

 

Date: November 8, 2021

 

By:

/s/ H. Baird Radford, III

 

 

 

H. Baird Radford, III
Chief Financial Officer

 

 

 

 

 

2


EX-99.1

https://cdn.kscope.io/28e04deee4d694452eca3ea2d9af0d5e-img113759291_0.jpg 

Exhibit 99.1

 

Allakos Provides Business Update and Reports Third Quarter 2021 Financial Results

REDWOOD CITY, Calif., November 8, 2021 (GLOBE NEWSWIRE) – Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today provided a business update and reported financial results for the third quarter ended September 30, 2021.

Recent Accomplishments

Presented data at American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting from prospective study showing high prevalence rates of eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) with systemic evaluation. Forty-five percent (45%, 181/405) of patients with moderate-to-severe unexplained gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD. This data suggests that these conditions are significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms.

Upcoming 2021 Milestones

Topline data from a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021 or early in the first quarter of 2022.
Topline data from a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EoE expected in the fourth quarter of 2021 or early in the first quarter of 2022.
Initiation of a Phase 2/3 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the fourth quarter of 2021.
Initiation of a Phase 2 randomized, double-blind, placebo-controlled study in a non-eosinophilic gastrointestinal disease in the fourth quarter of 2021.

Third Quarter 2021 Financial Results

Research and development expenses were $43.6 million in the third quarter of 2021 as compared to $30.4 million in the same period in 2020, an increase of $13.2 million.

General and administrative expenses were $19.1 million in the third quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $7.0 million.

Allakos reported a net loss of $62.7 million in the third quarter of 2021 as compared to $42.1 million in the same period in 2020, an increase of $20.6 million. Net loss per basic and diluted share was $1.16 for the third quarter of 2021 compared to $0.86 in the same period in 2020.

Allakos ended the third quarter of 2021 with $505.6 million in cash, cash equivalents and marketable securities.

 


 

About Allakos

Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. 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’ progress and business plans, the expected timing of anticipated study results and plans relating to its future clinical trials. 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 complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos’ ability to obtain required regulatory approvals for its product candidates; 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 later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; 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 lirentelimab; Allakos’ ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos’ most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, Quarterly Report on Form 10-Q filed with the SEC on November 8, 2021, and future reports to be filed 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 and COO

Alex Schwartz, VP Strategic Finance and Investor Relations

ir@allakos.com

 

Media Contact:

Denise Powell

denise@redhousecomms.com

 

 

 


 

Allakos Inc.

Statements of Operations and Comprehensive Loss

(in thousands, except per share data)

(Unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

43,560

 

 

$

30,380

 

 

$

123,460

 

 

$

77,011

 

General and administrative

 

 

19,056

 

 

 

12,055

 

 

 

51,936

 

 

 

35,701

 

Total operating expenses

 

 

62,616

 

 

 

42,435

 

 

 

175,396

 

 

 

112,712

 

Loss from operations

 

 

(62,616

)

 

 

(42,435

)

 

 

(175,396

)

 

 

(112,712

)

Interest income

 

 

74

 

 

 

766

 

 

 

307

 

 

 

4,039

 

Other expense, net

 

 

(187

)

 

 

(417

)

 

 

(407

)

 

 

(529

)

Net loss

 

 

(62,729

)

 

 

(42,086

)

 

 

(175,496

)

 

 

(109,202

)

Unrealized gain (loss) on marketable
   securities

 

 

(13

)

 

 

(620

)

 

 

11

 

 

 

30

 

Comprehensive loss

 

$

(62,742

)

 

$

(42,706

)

 

$

(175,485

)

 

$

(109,172

)

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(1.16

)

 

$

(0.86

)

 

$

(3.27

)

 

$

(2.24

)

Weighted-average number of common
   shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

54,069

 

 

 

48,950

 

 

 

53,644

 

 

 

48,819

 

 

 

 

 

 


 

allakos inc.

CONDENSED balance sheets

(in thousands)

 

 

 

September 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

274,420

 

 

$

207,177

 

Investments in marketable securities

 

 

231,187

 

 

 

451,820

 

Prepaid expenses and other current assets

 

 

25,843

 

 

 

10,270

 

Total current assets

 

 

531,450

 

 

 

669,267

 

Property and equipment, net

 

 

40,329

 

 

 

8,345

 

Operating lease right-of-use assets

 

 

37,174

 

 

 

39,731

 

Other long-term assets

 

 

12,125

 

 

 

2,275

 

Total assets

 

$

621,078

 

 

$

719,618

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

8,808

 

 

$

13,960

 

Accrued expenses and other current liabilities

 

 

31,815

 

 

 

8,490

 

Total current liabilities

 

 

40,623

 

 

 

22,450

 

Operating lease liabilities, net of current portion

 

 

55,902

 

 

 

42,773

 

Total liabilities

 

 

96,525

 

 

 

65,223

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

54

 

 

 

53

 

Additional paid-in capital

 

 

1,042,940

 

 

 

997,298

 

Accumulated other comprehensive gain

 

 

19

 

 

 

8

 

Accumulated deficit

 

 

(518,460

)

 

 

(342,964

)

Total stockholders’ equity

 

 

524,553

 

 

 

654,395

 

Total liabilities and stockholders’ equity

 

$

621,078

 

 

$

719,618