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Allakos Inc. (ALLK) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Allakos Inc.

CIK: 1564824 Ticker: ALLK

Exhibit 99.1

 

Allakos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

REDWOOD CITY, Calif., March 1, 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 fourth quarter and full year ended December 31, 2020 and provided a business update.

2020 Accomplishments

 

Announced positive results from our prospective prevalence study showing that 45% (181/405) of symptomatic patients biopsied with chronic unexplained gastrointestinal (GI) symptoms or functional gastrointestinal disorders (FGIDs) such as irritable bowel syndrome (IBS) and functional dyspepsia (FD) met the histologic criteria for eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). The results suggest that EG and/or EoD are significantly underdiagnosed among these patients. Millions of patients in the U.S. are under the care of a gastroenterologist and suffer from chronic unexplained gastrointestinal symptoms or FGIDs. These results provide evidence that prevalence of EG and EoD is significantly higher than reported in the literature.

 

Announced positive safety, pharmacokinetic and pharmacodynamic results from a randomized, double-blind, placebo-controlled Phase 1 study of subcutaneous (SC) lirentelimab in healthy volunteers. Bioavailability of SC lirentelimab was 63% and SC lirentelimab resulted in extended eosinophil suppression at all dose levels tested. At dose levels of 3.0 and 5.0 mg/kg and with the fixed dose of 300 mg, SC lirentelimab resulted in eosinophil suppression in all subjects through Day 85. The pharmacokinetic and pharmacodynamic results suggest that SC lirentelimab may be given monthly or potentially less frequently. SC lirentelimab was well tolerated, and there were no serious adverse events, no injection site reactions and no infusion-related reactions with SC lirentelimab.

 

Published results from a Phase 2 study of lirentelimab in patients with EG and/or EoD (ENIGMA) in the New England Journal of Medicine.

 

Announced positive interim results from an open-label long term extension study of ENIGMA. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting.

 

Closed an underwritten public offering, issuing 3,506,098 shares of common stock at an offering price of $82.00 per share. Aggregate net proceeds received from the offering were approximately $271.7 million, after deducting underwriting discounts and commissions.

Upcoming 2021 Milestones

 

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

 

Initiation of a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EoD expected in the second quarter of 2021.


The following information was filed by Allakos Inc. (ALLK) on Monday, March 1, 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 Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Balance Sheets (Unaudited)
Balance Sheets (Unaudited) (Parenthetical)
Statements Of Cash Flows (Unaudited)
Statements Of Operations And Comprehensive Loss (Unaudited)
Statements Of Stockholders' Equity (Unaudited)
Balance Sheet Components And Supplemental Disclosures
Balance Sheet Components And Supplemental Disclosures (Tables)
Balance Sheet Components And Supplemental Disclosures - Additional Information (Details)
Balance Sheet Components And Supplemental Disclosures - Schedule Of Accrued Expenses And Other Current Liabilities (Details)
Balance Sheet Components And Supplemental Disclosures - Schedule Of Property And Equipment, Net (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Summary Of Classification Of Company's Operating Lease Liabilities (Details)
Commitments And Contingencies - Summary Of Components Of Lease Costs (Details)
Commitments And Contingencies - Summary Of Future Lease Payments Required Under Operating Leases (Details)
Defined Contribution Plans
Defined Contribution Plans - Additional Information (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Details)
Fair Value Measurements - Summary Of Financial Assets Measured At Fair Value On Recurring Basis (Details)
Marketable Securities
Marketable Securities (Tables)
Marketable Securities - Additional Information (Details)
Marketable Securities - Marketable Securities - Summary Of Amortized Cost, Gross Unrealized Holding Gains Or Losses, And Fair Value Of Marketable Securities (Details)
Organization And Business
Organization And Business - Additional Information (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Summary Of Rsu Activity Under 2018 Plan (Details)
Stock-Based Compensation - Summary Of Stock Option Activity (Details)
Stock-Based Compensation - Summary Of Total Stock-Based Compensation Expense Recognized (Details)
Stock-Based Compensation - Summary Of Weighted-Average Assumptions Used To Calculate Fair Value Of Stock Options Granted (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Calculation Of Basic And Diluted Net Loss Per Share (Details)
Summary Of Significant Accounting Policies - Reconciliation Of Cash, Cash Equivalents And Restricted Cash (Details)
Summary Of Significant Accounting Policies - Summary Of Potentially Dilutive Securities Excluded From Calculation Of Diluted Net Loss Per Share (Details)
Ticker: ALLK
CIK: 1564824
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-026059
Submitted to the SEC: Mon May 10 2021 4:14:12 PM EST
Accepted by the SEC: Mon May 10 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations

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