Allakos Provides Business Update and Reports Third Quarter 2023 Financial Results
Recent Allakos Events
- Completed enrollment in both the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis and the Phase 2b study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria (“CSU”).
- Began dosing patients in the Phase 1 study of AK006. The Phase 1 study is a single and multiple ascending dose study of AK006 in healthy volunteers. In addition, the Phase 1 study will explore the activity of AK006 in a randomized, double-blind, placebo-controlled cohort of patients with CSU.
- Appointed
Neil Graham , M.D.,Rand Sutherland , M.D., andDolca Thomas , M.D. to the Allakos Board of Directors.
Upcoming Allakos Anticipated Milestones
- Topline data expected from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in late Q4 2023 to Q1 2024.
- Topline data expected from the Phase 2b study of subcutaneous lirentelimab in patients with CSU in late Q4 2023 to Q1 2024.
- Following the single and multiple ascending dose portions of the Phase 1 AK006 study in healthy volunteers, initiation of the randomized, double-blind, placebo-controlled cohort in patients with CSU is expected in Q2 2024.
Third Quarter 2023 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’ progress, business plans and areas of focus, the expected timing of reporting topline data from its Phase 2 and 2b clinical trials of lirentelimab, the clinical potential of Allakos’ antibodies and the progress of a Phase 1 study of AK006. 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 initiate and complete clinical trials for lirentelimab and AK006; Allakos’ ability to obtain required regulatory approvals for its clinical trials; 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 clinical trials, regardless of the outcomes of preclinical testing or early-stage trials; Allakos’ ability to obtain regulatory approvals to market its product candidates; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases
Source:
Investor Contact:
ir@allakos.com
Media Contact:
denise@redhousecomms.com
ALLAKOS INC. | ||||||||||||||||
UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 36,749 | $ | 18,438 | $ | 97,107 | $ | 229,693 | ||||||||
General and administrative | 11,461 | 13,007 | 33,966 | 46,520 | ||||||||||||
Total operating expenses | 48,210 | 31,445 | 131,073 | 276,213 | ||||||||||||
Loss from operations | (48,210 | ) | (31,445 | ) | (131,073 | ) | (276,213 | ) | ||||||||
Interest income | 2,590 | 711 | 7,965 | 898 | ||||||||||||
Other expense, net | (6 | ) | (103 | ) | (42 | ) | (1,648 | ) | ||||||||
Net loss | (45,626 | ) | (30,837 | ) | (123,150 | ) | (276,963 | ) | ||||||||
Unrealized gain on investments | 87 | 196 | 212 | 89 | ||||||||||||
Comprehensive loss | $ | (45,539 | ) | $ | (30,641 | ) | $ | (122,938 | ) | $ | (276,874 | ) | ||||
Net loss per common share: | ||||||||||||||||
Basic and diluted | $ | (0.52 | ) | $ | (0.53 | ) | $ | (1.42 | ) | $ | (4.95 | ) | ||||
Weighted-average number of common shares outstanding: | ||||||||||||||||
Basic and diluted | 87,115 | 58,169 | 86,539 | 55,905 |
UNAUDITED CONDENSED BALANCE SHEETS | ||||||||
(in thousands) | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 70,519 | $ | 87,217 | ||||
Investments | 123,389 | 192,569 | ||||||
Prepaid expenses and other current assets | 24,371 | 29,057 | ||||||
Total current assets | 218,279 | 308,843 | ||||||
Property and equipment, net | 34,965 | 39,144 | ||||||
Operating lease right-of-use assets | 24,167 | 30,225 | ||||||
Other long-term assets | 6,084 | 8,208 | ||||||
Total assets | $ | 283,495 | $ | 386,420 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 915 | $ | 4,832 | ||||
Accrued expenses and other current liabilities | 22,535 | 25,206 | ||||||
Total current liabilities | 23,450 | 30,038 | ||||||
Operating lease liabilities, net of current portion | 39,002 | 45,949 | ||||||
Total liabilities | 62,452 | 75,987 | ||||||
Stockholders’ equity: | ||||||||
Common stock | 87 | 85 | ||||||
Additional paid-in capital | 1,276,954 | 1,243,408 | ||||||
Accumulated other comprehensive loss | (72 | ) | (284 | ) | ||||
Accumulated deficit | (1,055,926 | ) | (932,776 | ) | ||||
Total stockholders’ equity | 221,043 | 310,433 | ||||||
Total liabilities and stockholders’ equity | $ | 283,495 | $ | 386,420 |
Source: Allakos Inc.