Allakos Inc. (ALLK) 10-K Annual Report March 2022

– Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2021.

Recent Events

•

Initiated a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis in the fourth quarter of 2021.

•

Reported topline data from ENIGMA 2, a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic gastritis/eosinophilic duodenitis (“EG”/“EoD”) in the fourth quarter of 2021.

•

Reported topline data from KRYPTOS, a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic esophagitis (“EoE”) in the fourth quarter of 2021.

Upcoming Milestones

•

Hold an End-of-Phase 2 meeting with the FDA during second quarter of 2022 to discuss the Phase 2/3 KRYPTOS data and the development path with subcutaneous lirentelimab in patients with EoE.

•

Report topline data from the Phase 3 study of lirentelimab in patients with EoD (EoDyssey) in the third quarter of 2022.

•

Initiate a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the middle of 2022.

•

Complete IND-Enabling studies of AK006 during 2022 and initiate the first-in-human study in the first half of 2023.

Fourth Quarter and Full Year 2021 Financial Results

Research and development expenses were $72.9 million in the fourth quarter of 2021 as compared to $28.5 million in the same period in 2020, an increase of $44.4 million. Research and development expenses were $196.3 million for the full year 2021 as compared to $105.5 million in the same period in 2020, an increase of $90.8 million.

General and administrative expenses were $23.2 million in the fourth quarter of 2021 as compared to $15.8 million in the same period in 2020, an increase of $7.4 million. General and administrative expenses were $75.1 million for the full year 2021 as compared to $51.5 million in the same period in 2020, an increase of $23.6 million.

Allakos reported a net loss of $94.4 million in the fourth quarter of 2021 as compared to $44.3 million in the same period in 2020, an increase of $50.1 million. Net loss per basic and diluted share was $1.73 for the fourth quarter of 2021 compared to $0.86 in the same period in 2020. Net loss was $269.9 million for the full year 2021 as compared to $153.5 million in the same period in 2020, an increase of $116.4 million. Net

The following information was filed by Allakos Inc. (ALLK) on Tuesday, March 1, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Allakos Inc.'s 10-K Annual Report:

Financial - Expense Highlight
Results of Operations The following table summarizes our results of operations for the periods indicated (in thousands): Comparison of the Years Ended December 31, 2021 and 2020 Research and Development Expenses Research and development expenses consist primarily of discovery, development and manufacturing of our non-commercial products, clinical trial costs (including payments to contract research organizations, or CROs), salaries and other personnel costs, preclinical study fees, research supply costs, facility and equipment costs and allocations of facilities and other overhead costs.

Financial - Expense Highlight
In February 2022, we began implementing a reorganization plan (the Reorganization Plan) to reduce operating costs, contractual commitments and better align our workforce with the clinical development plans of our business.
Financial - Expense Highlight
The period-over-period increase in general and administrative expenses was primarily attributable to an increase of $16.2 million in increased personnel-related costs due to increased headcount and includes an increase of $9.1 million in stock-based compensation expense.
Financial - Expense Highlight
Noncash charges included $50.8 million in stock-based compensation expense, $3.4 million in net amortization of premiums and discounts on marketable securities, $2.3 million in depreciation and amortization expense, $2.6 million in noncash lease expense and $1.9 million in gains from a lease modification.
Other - Other Highlight
In the event of a contract being terminated, we would only be obligated for services received as of the effective date of the termination, along with cancellation fees, as applicable.
Other - Other
As the financial terms included...Read more
Financial - Expense
Research and development expense associated...Read more
Financial - Expense
Noncash charges included $33.4 million...Read more
Financial - Income
Interest Income Interest income was...Read more
Financial - Expense
Consulting and personnel-related costs, laboratory...Read more
Financial - Expense
General and administrative expenses were...Read more
Financial - Expense
The following table summarizes our...Read more
Financial - Income
Other Income (Expense), Net Other...Read more
Financial - Expense
To date, we have not...Read more
Other - Other
Based on our existing business...Read more
Other - Other
We believe that the Reorganization...Read more
Revenue - Product
The Sales Agreement was terminated...Read more
Revenue - Product
On February 14, 2022 (the...Read more
Other - Other
If we fail to pay...Read more
Financial - Expense
We anticipate that our general...Read more
Financial - Income
Other income (expense), net, for...Read more
Financial - Income
Our deferred income tax assets...Read more
Other - Other
We believe that the Reorganization...Read more
Revenue - Product
Pursuant to the terms of...Read more
Other - Other
In some cases, you can...Read more
Financial - Expense
We anticipate that our research...Read more
Financial - Expense
The capitalized amounts are expensed...Read more
M & A - Other
Additionally, patients in the ENIGMA...Read more
Financial - Expense
Prior to the regulatory approval...Read more
Other - Other
The Termination Agreement provides that...Read more
Other - Other
Lease liabilities represent the present...Read more
Financial - Income
We assess all material positions...Read more
Other - Other
We have incurred significant operating...Read more
Other - Other
Approximately $231.2 million of the...Read more
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We track these costs on...Read more
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A change pertaining to any...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Allakos Inc. provided additional information to their SEC Filing as exhibits

Exhibit 4.3: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.19: Material Contract

Exhibit 10.21: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: ALLK
CIK: 1564824
Form Type: 10-K Annual Report
Accession Number: 0000950170-22-002542
Submitted to the SEC: Tue Mar 01 2022 4:18:23 PM EST
Accepted by the SEC: Tue Mar 01 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations