Allakos Provides Business Update and Reports Second Quarter 2022 Financial Results
Recent Allakos Events
- Submitted End-of-Phase 2 briefing package to FDA to discuss Phase 2 KRYPTOS data and development pathway of lirentelimab in patients with eosinophilic esophagitis (EoE). Meeting with FDA scheduled for third quarter of 2022.
Upcoming Allakos Milestones
- Report topline data from Phase 3 EoDyssey study of lirentelimab (AK002) in patients with eosinophilic duodenitis (EoD) in third quarter of 2022.
- Hold End-of-Phase 2 meeting with FDA during third quarter of 2022 to discuss Phase 2 KRYPTOS data and development path.
- Initiate Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in third quarter of 2022.
- Complete IND-enabling studies of AK006 by end of fourth quarter of 2022 and initiate first-in-human study in first half of 2023.
- Report topline data from Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in second half of 2023.
- Report topline data from Phase 2 study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in second half of 2023.
Second Quarter 2022 Financial Results
Research and development expenses were
General and administrative expenses were
About
Forward-Looking Statements
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’ business plans and product candidates’ progress, the expected timing of FDA discussions and anticipated study results and the reporting of such results, plans relating to Allakos’ future IND-enabling studies and clinical trials, and Allakos’ upcoming milestones. 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 prior clinical trials; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases
Source:
UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 34,448 | $ | 40,985 | $ | 211,255 | $ | 79,900 | ||||||||
| General and administrative | 14,669 | 16,210 | 33,513 | 32,880 | ||||||||||||
| Total operating expenses | 49,117 | 57,195 | 244,768 | 112,780 | ||||||||||||
| Loss from operations | (49,117 | ) | (57,195 | ) | (244,768 | ) | (112,780 | ) | ||||||||
| Interest income | 104 | 103 | 187 | 233 | ||||||||||||
| Other expense, net | (90 | ) | (117 | ) | (1,545 | ) | (220 | ) | ||||||||
| Net loss | (49,103 | ) | (57,209 | ) | (246,126 | ) | (112,767 | ) | ||||||||
| Unrealized gain (loss) on investments | 209 | (56 | ) | (107 | ) | 24 | ||||||||||
| Comprehensive loss | $ | (48,894 | ) | $ | (57,265 | ) | $ | (246,233 | ) | $ | (112,743 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (0.90 | ) | $ | (1.07 | ) | $ | (4.50 | ) | $ | (2.11 | ) | ||||
| Weighted-average number of common shares outstanding: | ||||||||||||||||
| Basic and diluted | 54,798 | 53,669 | 54,742 | 53,429 | ||||||||||||
UNAUDITED CONDENSED BALANCE SHEETS
(in thousands)
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 82,452 | $ | 152,822 | ||||
| Investments | 129,987 | 271,416 | ||||||
| Prepaid expenses and other current assets | 9,427 | 27,343 | ||||||
| Total current assets | 221,866 | 451,581 | ||||||
| Property and equipment, net | 41,300 | 43,100 | ||||||
| Operating lease right-of-use assets | 31,962 | 31,707 | ||||||
| Other long-term assets | 11,781 | 8,436 | ||||||
| Total assets | $ | 306,909 | $ | 534,824 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 9,865 | $ | 13,692 | ||||
| Accrued expenses and other current liabilities | 26,638 | 26,557 | ||||||
| Total current liabilities | 36,503 | 40,249 | ||||||
| Operating lease liabilities, net of current portion | 47,597 | 49,099 | ||||||
| Total liabilities | 84,100 | 89,348 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 54 | 54 | ||||||
| Additional paid-in capital | 1,081,965 | 1,058,399 | ||||||
| Accumulated other comprehensive loss | (260 | ) | (153 | ) | ||||
| Accumulated deficit | (858,950 | ) | (612,824 | ) | ||||
| Total stockholders’ equity | 222,809 | 445,476 | ||||||
| Total liabilities and stockholders’ equity | $ | 306,909 | $ | 534,824 | ||||
Investor Contact:Adam Tomasi , President and COOAlex Schwartz , VP Strategic Finance and Investor Relations ir@allakos.com Media Contact:Denise Powell denise@redhousecomms.com
Source: Allakos Inc.