REDWOOD CITY, Calif., Aug. 09, 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 second quarter ended June 30, 2021.
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 $41.0 million in the second quarter of 2021 as compared to $28.3 million in the same period in 2020, an increase of $12.7 million.
General and administrative expenses were $16.2 million in the second quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $4.1 million.
Allakos reported a net loss of $57.2 million in the second quarter of 2021 as compared to $39.3 million in the same period in 2020, an increase of $17.9 million. Net loss per basic and diluted share was $1.07 for the second quarter of 2021 compared to $0.80 in the same period in 2020.
Allakos ended the second quarter of 2021 with $559.7 million in cash, cash equivalents and marketable securities.
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 August 9, 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.
ALLAKOS INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
(Unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALLAKOS INC.
CONDENSED BALANCE SHEETS
(in thousands)
|
|
June 30, |
|
|
December 31, |
|
|
|
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
