Allakos Provides Business Update and Reports Second Quarter 2021 Financial Results
Recent Accomplishments
- Presented new data at Digestive Disease Week (DDW) 2021 suggesting eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms. Forty-five percent (45%, 181/405) of patients with chronic functional gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD.
- Completed patient enrollment in Phase 3 EG/EoD and Phase 2/3 eosinophilic esophagitis (EoE) clinical trials of lirentelimab (AK002).
Upcoming 2021 Milestones
- Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021.
- Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with EoE expected in the fourth quarter of 2021.
- Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
- Initiation of a Phase 2 study in a non-eosinophilic gastrointestinal disease in the second half of 2021.
Second Quarter 2021 Financial Results
Research and development expenses were
General and administrative expenses were
About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.
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 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
Source:
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 40,985 | $ | 28,346 | $ | 79,900 | $ | 46,631 | ||||||||
| General and administrative | 16,210 | 12,058 | 32,880 | 23,646 | ||||||||||||
| Total operating expenses | 57,195 | 40,404 | 112,780 | 70,277 | ||||||||||||
| Loss from operations | (57,195 | ) | (40,404 | ) | (112,780 | ) | (70,277 | ) | ||||||||
| Interest income | 103 | 1,284 | 233 | 3,273 | ||||||||||||
| Other expense, net | (117 | ) | (172 | ) | (220 | ) | (112 | ) | ||||||||
| Net loss | (57,209 | ) | (39,292 | ) | (112,767 | ) | (67,116 | ) | ||||||||
| Unrealized gain (loss) on marketable securities |
(56 | ) | (1,219 | ) | 24 | 650 | ||||||||||
| Comprehensive loss | $ | (57,265 | ) | $ | (40,511 | ) | $ | (112,743 | ) | $ | (66,466 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (1.07 | ) | $ | (0.80 | ) | $ | (2.11 | ) | $ | (1.38 | ) | ||||
| Weighted-average number of common shares outstanding: |
||||||||||||||||
| Basic and diluted | 53,669 | 48,816 | 53,429 | 48,753 | ||||||||||||
CONDENSED BALANCE SHEETS
(in thousands)
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 203,956 | $ | 207,177 | ||||
| Investments in marketable securities | 355,739 | 451,820 | ||||||
| Prepaid expenses and other current assets | 16,363 | 10,270 | ||||||
| Total current assets | 576,058 | 669,267 | ||||||
| Property and equipment, net | 25,034 | 8,345 | ||||||
| Operating lease right-of-use assets | 37,736 | 39,731 | ||||||
| Other long-term assets | 16,119 | 2,275 | ||||||
| Total assets | $ | 654,947 | $ | 719,618 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 15,663 | $ | 13,960 | ||||
| Accrued expenses and other current liabilities | 18,335 | 8,490 | ||||||
| Total current liabilities | 33,998 | 22,450 | ||||||
| Operating lease liabilities, net of current portion | 49,963 | 42,773 | ||||||
| Total liabilities | 83,961 | 65,223 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 53 | 53 | ||||||
| Additional paid-in capital | 1,026,632 | 997,298 | ||||||
| Accumulated other comprehensive gain | 32 | 8 | ||||||
| Accumulated deficit | (455,731 | ) | (342,964 | ) | ||||
| Total stockholders’ equity | 570,986 | 654,395 | ||||||
| Total liabilities and stockholders’ equity | $ | 654,947 | $ | 719,618 | ||||
Investor Contact:Adam Tomasi , President and COO ir@allakos.com Media Contact:Denise Powell denise@redhousecomms.com
Source: Allakos Inc.