Allakos Inc. (ALLK) 10-Q Quarterly Report August 2021

– Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.

Recent Accomplishments

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Announced the acceptance of two oral and five poster presentations at the Digestive Disease Week (DDW) Annual Meeting taking place May 21 to 23, 2021. ePosters and ePapers will be available from the DDW ePosters and ePapers website. Abstracts can now be found here.

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Initiated a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with eosinophilic duodenitis.

Upcoming 2021 Milestones

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

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

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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.

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

First Quarter 2021 Financial Results

Research and development expenses were $38.9 million in the first quarter of 2021 as compared to $18.3 million in the same period in 2020, an increase of $20.6 million.

General and administrative expenses were $16.7 million in the first quarter of 2021 as compared to $11.6 million in the same period in 2020, an increase of $5.1 million.

Allakos reported a net loss of $55.6 million in the first quarter of 2021 as compared to $27.8 million in the same period in 2020, an increase of $27.8 million. Net loss per basic and diluted share was $1.04 for the first quarter of 2021 compared to $0.57 in the same period in 2020.

Allakos ended the first quarter of 2021 with $615.9 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).

The following information was filed by Allakos Inc. (ALLK) on Monday, May 10, 2021 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-Q Quarterly 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-Q Quarterly Report:

Financial - Expense Highlight
The period-over-period increase in general and administrative expenses includes an additional $1.9 million of consulting and personnel-related costs associated primarily attributable to increased hiring of G&A personnel, including associated stock-based compensation expense.

Financial - Expense Highlight
The following table summarizes our research and development expenses for the periods indicated (in thousands): We anticipate that our research and development expenses will increase in the future, primarily driven by costs associated with the manufacturing of our lead product candidate, lirentelimab, as we continue to increase the frequency and scale of our manufacturing batches in anticipation of a commercial launch if we are able to obtain FDA approval.
Financial - Expense Highlight
The period-over-period increase in general and administrative expenses was primarily attributable to an additional $4.7 million of personnel-related costs, including associated stock-based compensation expense.
Financial - Expense Highlight
Noncash charges included approximately $23.8 million in stock-based compensation expense, $1.5 million in noncash lease expense, $1.2 million in amortization of premiums and discounts on marketable securities and $0.8 million in depreciation and amortization expense.
Financial - Expense Highlight
Noncash charges included approximately $15.2 million in stock-based compensation expense, $1.0 million in amortization of premiums and discounts on marketable securities, $0.8 million in depreciation and amortization expense and $0.1 million in noncash lease expense.
Other - Other
In the event of a...Read more
Financial - Expense
Research and development expense associated...Read more
Financial - Expense
The period-over-period increase in research...Read more
Other - Other
ENIGMA patients that continued to...Read more
Financial - Expense
Consulting and personnel-related costs, laboratory...Read more
Financial - Expense
To date, we have not...Read more
Other - Other
Based on our existing business...Read more
Financial - Expense
General and Administrative Expenses General...Read more
Financial - Expense
General and Administrative Expenses General...Read more
Financial - Expense
We anticipate that our general...Read more
Revenue - Product
Pursuant to the terms of...Read more
Other - Other
In some cases, you can...Read more
Financial - Income
Interest Income Interest income was...Read more
Financial - Income
Interest Income Interest income was...Read more
Financial - Expense
We incurred $3.4 million of...Read more
Financial - Expense
21 The following table summarizes...Read more
Financial - Expense
The following table summarizes our...Read more
Financial - Expense
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M & A - Other
Additionally, patients in the ENIGMA...Read more
Financial - Expense
Other expense, net, primarily consists...Read more
Financial - Expense
Prior to the regulatory approval...Read more
Other - Other
The Company expects to enter...Read more
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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

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-Q Quarterly Report
Accession Number: 0001564590-21-042638
Submitted to the SEC: Mon Aug 09 2021 4:12:12 PM EST
Accepted by the SEC: Mon Aug 09 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations