Allakos Provides Business Update and Reports Third Quarter 2021 Financial Results
Allakos Inc. (Nasdaq: ALLK) provided a business update and reported its Q3 2021 financial results on November 8, 2021. The company presented data indicating a high prevalence of eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD), with 45% of patients meeting diagnostic criteria. Upcoming milestones include topline data for lirentelimab studies in EG/EoD and EoE expected in late 2021 or early 2022. Financially, R&D expenses rose to $43.6 million, while general and administrative expenses increased to $19.1 million. The net loss was $62.7 million, amounting to $1.16 per share, with $505.6 million in cash at quarter-end.
- Presentation of significant data showing underdiagnosis of EG/EoD potentially leading to increased market interest.
- Upcoming topline data from multiple Phase 2/3 studies expected soon.
- Increased research and development expenses of $43.6 million, up from $30.4 million in Q3 2020.
- Substantial net loss of $62.7 million, an increase of $20.6 million from the previous year.
REDWOOD CITY, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today provided a business update and reported financial results for the third quarter ended September 30, 2021.
Recent Accomplishments
- Presented data at American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting from prospective study showing high prevalence rates of eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) with systemic evaluation. Forty-five percent (
45% , 181/405) of patients with moderate-to-severe unexplained gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD. This data suggests that these conditions are significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms.
Upcoming 2021 Milestones
- Topline data from a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021 or early in the first quarter of 2022.
- Topline data from a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EoE expected in the fourth quarter of 2021 or early in the first quarter of 2022.
- Initiation of a Phase 2/3 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the fourth quarter of 2021.
- Initiation of a Phase 2 randomized, double-blind, placebo-controlled study in a non-eosinophilic gastrointestinal disease in the fourth quarter of 2021.
Third Quarter 2021 Financial Results
Research and development expenses were
General and administrative expenses were
Allakos reported a net loss of
Allakos ended the third quarter of 2021 with
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 Allakos is targeting; Allakos’ ability to advance additional product candidates beyond lirentelimab; Allakos’ ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos’ most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, Quarterly Report on Form 10-Q filed with the SEC on November 8, 2021, and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release.
Source: Allakos Inc.
Investor Contact:
Adam Tomasi, President and COO
Alex Schwartz, VP Strategic Finance and Investor Relations
ir@allakos.com
Media Contact:
Denise Powell
denise@redhousecomms.com
| ALLAKOS INC. | ||||||||||||||||
| STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 43,560 | $ | 30,380 | $ | 123,460 | $ | 77,011 | ||||||||
| General and administrative | 19,056 | 12,055 | 51,936 | 35,701 | ||||||||||||
| Total operating expenses | 62,616 | 42,435 | 175,396 | 112,712 | ||||||||||||
| Loss from operations | (62,616 | ) | (42,435 | ) | (175,396 | ) | (112,712 | ) | ||||||||
| Interest income | 74 | 766 | 307 | 4,039 | ||||||||||||
| Other expense, net | (187 | ) | (417 | ) | (407 | ) | (529 | ) | ||||||||
| Net loss | (62,729 | ) | (42,086 | ) | (175,496 | ) | (109,202 | ) | ||||||||
| Unrealized gain (loss) on marketable securities | (13 | ) | (620 | ) | 11 | 30 | ||||||||||
| Comprehensive loss | $ | (62,742 | ) | $ | (42,706 | ) | $ | (175,485 | ) | $ | (109,172 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (1.16 | ) | $ | (0.86 | ) | $ | (3.27 | ) | $ | (2.24 | ) | ||||
| Weighted-average number of common shares outstanding: | ||||||||||||||||
| Basic and diluted | 54,069 | 48,950 | 53,644 | 48,819 | ||||||||||||
| ALLAKOS INC. | ||||||||
| CONDENSED BALANCE SHEETS | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 274,420 | $ | 207,177 | ||||
| Investments in marketable securities | 231,187 | 451,820 | ||||||
| Prepaid expenses and other current assets | 25,843 | 10,270 | ||||||
| Total current assets | 531,450 | 669,267 | ||||||
| Property and equipment, net | 40,329 | 8,345 | ||||||
| Operating lease right-of-use assets | 37,174 | 39,731 | ||||||
| Other long-term assets | 12,125 | 2,275 | ||||||
| Total assets | $ | 621,078 | $ | 719,618 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,808 | $ | 13,960 | ||||
| Accrued expenses and other current liabilities | 31,815 | 8,490 | ||||||
| Total current liabilities | 40,623 | 22,450 | ||||||
| Operating lease liabilities, net of current portion | 55,902 | 42,773 | ||||||
| Total liabilities | 96,525 | 65,223 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 54 | 53 | ||||||
| Additional paid-in capital | 1,042,940 | 997,298 | ||||||
| Accumulated other comprehensive gain | 19 | 8 | ||||||
| Accumulated deficit | (518,460 | ) | (342,964 | ) | ||||
| Total stockholders’ equity | 524,553 | 654,395 | ||||||
| Total liabilities and stockholders’ equity | $ | 621,078 | $ | 719,618 | ||||
FAQ
What are the key financial results reported by Allakos for Q3 2021?
What new data did Allakos present regarding eosinophilic disorders?
When are the upcoming milestones for Allakos expected?
How did Allakos' cash position change in Q3 2021?
