allk-8k_20210809.htm
false 0001564824 0001564824 2021-08-09 2021-08-09

 

 

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 9, 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)

(650597-5002

(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 August 9, 2021, Allakos Inc. (the “Company”) issued a press release reporting its financial results for the second quarter ended June 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 August 9, 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: August 9, 2021

 

By:

/s/ Robert Alexander

 

 

 

Robert Alexander

 

 

 

Chief Executive Officer

 

2

allk-ex991_6.htm

Exhibit 99.1

 

Allakos Provides Business Update and Reports Second Quarter 2021 Financial Results

REDWOOD CITY, Calif., August 9, 2021 – 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 second quarter ended June 30, 2021.

Recent Accomplishments

 

Presented new data at Digestive Disease Week (DDW) 2021 suggesting eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms. Forty-five percent (45%, 181/405) of patients with chronic functional gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD.

 

Completed patient enrollment in Phase 3 EG/EoD and Phase 2/3 eosinophilic esophagitis (EoE) clinical trials of lirentelimab (AK002).

Upcoming 2021 Milestones

 

Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021.

 

Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with EoE expected in the fourth quarter of 2021.

 

Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.

 

Initiation of a Phase 2 study in a non-eosinophilic gastrointestinal disease in the second half of 2021.

Second Quarter 2021 Financial Results

Research and development expenses were $41.0 million in the second quarter of 2021 as compared to $28.3 million in the same period in 2020, an increase of $12.7 million.

General and administrative expenses were $16.2 million in the second quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $4.1 million.

Allakos reported a net loss of $57.2 million in the second quarter of 2021 as compared to $39.3 million in the same period in 2020, an increase of $17.9 million. Net loss per basic and diluted share was $1.07 for the second quarter of 2021 compared to $0.80 in the same period in 2020.

Allakos ended the second quarter of 2021 with $559.7 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 August 9, 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:

 

Media Contact:

Adam Tomasi, President and COO

 

Denise Powell

ir@allakos.com

 

denise@redhousecomms.com


 

 

Allakos Inc.

Statements of Operations and Comprehensive Loss

(in thousands, except per share data)

(Unaudited)

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

40,985

 

 

$

28,346

 

 

$

79,900

 

 

$

46,631

 

General and administrative

 

 

16,210

 

 

 

12,058

 

 

 

32,880

 

 

 

23,646

 

Total operating expenses

 

 

57,195

 

 

 

40,404

 

 

 

112,780

 

 

 

70,277

 

Loss from operations

 

 

(57,195

)

 

 

(40,404

)

 

 

(112,780

)

 

 

(70,277

)

Interest income

 

 

103

 

 

 

1,284

 

 

 

233

 

 

 

3,273

 

Other expense, net

 

 

(117

)

 

 

(172

)

 

 

(220

)

 

 

(112

)

Net loss

 

 

(57,209

)

 

 

(39,292

)

 

 

(112,767

)

 

 

(67,116

)

Unrealized gain (loss) on marketable

   securities

 

 

(56

)

 

 

(1,219

)

 

 

24

 

 

 

650

 

Comprehensive loss

 

$

(57,265

)

 

$

(40,511

)

 

$

(112,743

)

 

$

(66,466

)

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(1.07

)

 

$

(0.80

)

 

$

(2.11

)

 

$

(1.38

)

Weighted-average number of common

   shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

53,669

 

 

 

48,816

 

 

 

53,429

 

 

 

48,753

 

 

 

 


 

 

allakos inc.

CONDENSED balance sheets

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

203,956

 

 

$

207,177

 

Investments in marketable securities

 

 

355,739

 

 

 

451,820

 

Prepaid expenses and other current assets

 

 

16,363

 

 

 

10,270

 

Total current assets

 

 

576,058

 

 

 

669,267

 

Property and equipment, net

 

 

25,034

 

 

 

8,345

 

Operating lease right-of-use assets

 

 

37,736

 

 

 

39,731

 

Other long-term assets

 

 

16,119

 

 

 

2,275

 

Total assets

 

$

654,947

 

 

$

719,618

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

15,663

 

 

$

13,960

 

Accrued expenses and other current liabilities

 

 

18,335

 

 

 

8,490

 

Total current liabilities

 

 

33,998

 

 

 

22,450

 

Operating lease liabilities, net of current portion

 

 

49,963

 

 

 

42,773

 

Total liabilities

 

 

83,961

 

 

 

65,223

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock

 

 

53

 

 

 

53

 

Additional paid-in capital

 

 

1,026,632

 

 

 

997,298

 

Accumulated other comprehensive gain

 

 

32

 

 

 

8

 

Accumulated deficit

 

 

(455,731

)

 

 

(342,964

)

Total stockholders’ equity

 

 

570,986

 

 

 

654,395

 

Total liabilities and stockholders’ equity

 

$

654,947

 

 

$

719,618