Allakos Provides Business Update and Reports First Quarter 2024 Financial Results
Recent Allakos Events
- Completed dosing in the single ascending dose (SAD) cohorts and multiple ascending dose (MAD) cohorts of the randomized, double-blind, placebo-controlled Phase 1 trial of Intravenous (IV) AK006 in healthy volunteers.
- Completed dosing in the randomized, double-blind, placebo-controlled subcutaneous (SC) AK006 cohort in healthy volunteers.
- Initiated the randomized, double-blind, placebo-controlled Phase 1 trial of IV AK006 in patients with chronic spontaneous urticaria.
- Published preclinical research in Allergy showing that AK006 controls mast cell function through interaction with multiple activating receptors and key signaling pathways.
- Presented preclinical data at the
American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting 2024 highlighting AK006’s mechanism of action and ability to reduce MRGPRX2-induced skin inflammation.
Upcoming Allakos Anticipated Milestones
- Report safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 trial of IV AK006 in healthy volunteers, including data to confirm Siglec-6 receptor occupancy in skin biopsy samples in Q2 2024.
- Report safety, PK, and PD results from the Phase 1 trial of SC AK006 in healthy volunteers, including data to confirm Siglec-6 receptor occupancy in skin biopsy samples in Q3 2024.
- Report topline data from the Phase 1 trial of IV AK006 in patients with CSU at year end 2024.
Cash Guidance
Allakos’ financial outlook, restructuring activities and estimated cash runway as reported by the Company in
First Quarter 2024 Financial Results
Research and development expenses were
General and administrative expenses were
In the first quarter of 2024,
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’ expected timing of reporting data from its clinical trial of AK006; cash guidance and runway; and restructuring. 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 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
UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except per share data) |
||||||||
| Three Months Ended | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 34,824 | $ | 33,078 | ||||
| General and administrative | 10,898 | 11,968 | ||||||
| Impairment of long-lived assets | 27,347 | — | ||||||
| Total operating expenses | 73,069 | 45,046 | ||||||
| Loss from operations | (73,069 | ) | (45,046 | ) | ||||
| Interest income | 1,995 | 2,678 | ||||||
| Other expense, net | (72 | ) | (36 | ) | ||||
| Net loss | (71,146 | ) | (42,404 | ) | ||||
| Unrealized gain (loss) on investments | (30 | ) | 296 | |||||
| Comprehensive loss | $ | (71,176 | ) | $ | (42,108 | ) | ||
| Net loss per common share: | ||||||||
| Basic and diluted | $ | (0.81 | ) | $ | (0.49 | ) | ||
| Weighted-average number of common shares outstanding: | ||||||||
| Basic and diluted | 88,042 | 85,845 | ||||||
UNAUDITED CONDENSED BALANCE SHEETS (in thousands) |
||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,060 | $ | 66,440 | ||||
| Investments | 96,192 | 104,354 | ||||||
| Prepaid expenses and other current assets | 8,382 | 9,095 | ||||||
| Total current assets | 147,634 | 179,889 | ||||||
| Property and equipment, net | 17,364 | 33,369 | ||||||
| Operating lease right-of-use assets | 10,577 | 24,136 | ||||||
| Other long-term assets | 1,737 | 6,216 | ||||||
| Total assets | $ | 177,312 | $ | 243,610 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 15,748 | $ | 1,764 | ||||
| Accrued expenses and other current liabilities | 20,173 | 34,814 | ||||||
| Total current liabilities | 35,921 | 36,578 | ||||||
| Operating lease liabilities, net of current portion | 37,408 | 38,215 | ||||||
| Total liabilities | 73,329 | 74,793 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 89 | 88 | ||||||
| Additional paid-in capital | 1,293,497 | 1,287,156 | ||||||
| Accumulated other comprehensive gain (loss) | 20 | 50 | ||||||
| Accumulated deficit | (1,189,623 | ) | (1,118,477 | ) | ||||
| Total stockholders’ equity | 103,983 | 168,817 | ||||||
| Total liabilities and stockholders’ equity | $ | 177,312 | $ | 243,610 | ||||
Source: Allakos Inc.