Allakos Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results
- 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.
- 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
General and administrative expenses were
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
UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended||Twelve Months Ended|
|Research and development||$||72,868||$||28,522||$||196,328||$||105,533|
|General and administrative||23,211||15,823||75,147||51,524|
|Total operating expenses||96,079||44,345||271,475||157,057|
|Loss from operations||(96,079||)||(44,345||)||(271,475||)||(157,057||)|
|Other income (expense), net||1,645||(207||)||1,238||(736||)|
|Unrealized loss on marketable
|Net loss per common share:|
|Basic and diluted||$||(1.73||)||$||(0.86||)||$||(5.01||)||$||(3.10||)|
|Weighted-average number of common
|Basic and diluted||54,391||51,475||53,832||49,492|
UNAUDITED CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||152,822||$||207,177|
|Investments in marketable securities||271,416||451,820|
|Prepaid expenses and other current assets||27,343||10,270|
|Total current assets||451,581||669,267|
|Property and equipment, net||43,100||8,345|
|Operating lease right-of-use assets||31,707||39,731|
|Other long-term assets||8,436||2,275|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||26,557||8,490|
|Total current liabilities||40,249||22,450|
|Operating lease liabilities, net of current portion||49,099||42,773|
|Additional paid-in capital||1,058,399||997,298|
|Accumulated other comprehensive gain (loss)||(153||)||8|
|Total stockholders’ equity||445,476||654,395|
|Total liabilities and stockholders’ equity||$||534,824||$||719,618|
Source: Allakos Inc.