On November 9, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the third quarter ended September 30, 2020 and provided an update of its ongoing development activities (Press release, Allakos, NOV 9, 2020, View Source [SID1234570320]).
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Business Updates
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. Since many people in the United States and worldwide suffer from chronic unexplained gastrointestinal symptoms or FGIDs, the results from this study suggest that EG and/or EoD may be more common than previously documented in the literature.
Announced positive safety, pharmacokinetic, and pharmacodynamic results from a randomized, double-blind, placebo-controlled Phase 1 study of subcutaneous lirentelimab in healthy volunteers. The results showed that subcutaneously administered lirentelimab had bioavailibity of 63% and suppressed eosinophils for up to 85 days. Subcutaneously administered lirentelimab was well tolerated with no serious adverse events, no injection site reactions, and no injection reactions/infusion-related reactions.
Announced the publication of the positive results from the Phase 2 study of lirentelimab in patients with EG and/or EoD (ENIGMA) in the New England Journal of Medicine.
Closed an underwritten public offering in November 2020, 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.
The randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG and/or EoD is ongoing with topline data expected in the second half of 2021.
The randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with eosinophilic esophagitis (EoE) is ongoing with topline data expected in the second half of 2021.
Third Quarter 2020 Financial Results
Research and development expenses were $30.4 million in the third quarter of 2020 as compared to $16.1 million in the same period in 2019, an increase of $14.3 million.
General and administrative expenses were $12.1 million in the third quarter of 2020 as compared to $7.5 million in the same period in 2019, an increase of $4.6 million.
Allakos reported a net loss of $42.1 million in the third quarter of 2020 as compared to $21.7 million in the same period in 2019, an increase of $20.4 million. Net loss per basic and diluted share was $0.86 for the third quarter of 2020 compared to $0.47 in the same period in 2019.
Allakos ended the third quarter of 2020 with $419.8 million in cash, cash equivalents and marketable securities, which does not include the $271.7 million of net proceeds received from the Company’s follow-on public offering in November 2020.