Allakos Provides Business Update and Reports First Quarter 2023 Financial Results
09 Mai 2023 - 10:02PM
Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology
company developing antibodies for the treatment of allergic,
inflammatory and proliferative diseases, today provided a business
update and reported financial results for the first quarter ended
March 31, 2023.
Recent Allakos Events
- Continued enrollment of a Phase 2 randomized, double-blind,
placebo-controlled study of subcutaneous lirentelimab in patients
with moderate-to-severe atopic dermatitis during the first quarter
of 2023.
- Continued enrollment of a Phase 2b randomized, double-blind,
placebo-controlled study of subcutaneous lirentelimab in patients
with chronic spontaneous urticaria (CSU) during the first quarter
of 2023.
Upcoming Allakos Anticipated Milestones
- Initiate the first-in-human study with AK006 in the first half
of 2023.
- Report topline data from the Phase 2 study of subcutaneous
lirentelimab in patients with atopic dermatitis in the second half
of 2023.
- Report topline data from the Phase 2b study of subcutaneous
lirentelimab in patients with chronic spontaneous urticaria in the
second half of 2023.
First Quarter 2023 Financial Results
Research and development expenses were $33.1 million in the
first quarter of 2023 compared to $176.8 million in the first
quarter of 2022. First quarter of 2023 research and development
expenses were significantly lower compared to the same period in
the prior year as a result of the cost reduction efforts and
reorganization plan implemented in the first quarter of 2022. The
first quarter of 2022 research and development expenses included
$130.5 million related to contract terminations and $4.6 million of
employee related costs due to the reorganization plan.
General and administrative expenses were $12.0 million for the
three months ended March 31, 2023 compared to $18.8 million for the
three months ended March 31, 2022, a decrease of $6.9 million. The
first quarter of 2022 general and administrative expenses included
$4.3 million of costs as a result of the reorganization plan. The
remaining decrease in general and administrative expenses from the
prior year first quarter was primarily due to decreases in
stock-based compensation expense and other general and
administrative expenses.
Allakos reported a net loss of $42.4 million in the first
quarter of 2023 compared to $197.0 million in the first quarter of
2022. Additionally, the first quarter of 2023 included non-cash
expenses for stock-based compensation of $10.7 million, compared to
$11.4 million in the same period in 2022, and depreciation of $1.5
million, compared to $2.1 million in the same period in 2022. Net
loss per basic and diluted share was $0.49 for the first quarter of
2023 compared to $3.60 in the first quarter of 2022.
Allakos ended the first quarter of 2023 with $252.6 million in
cash, cash equivalents and investments resulting in a net decrease
in cash and investments of $27.2 million during the first quarter
of 2023.
About Allakos
Allakos is a clinical stage biotechnology company developing
therapeutics which target immunomodulatory receptors present on
immune effector cells involved in allergy, inflammatory and
proliferative diseases. Activating these immunomodulatory receptors
allows for the direct targeting of cells involved in disease
pathogenesis and, in the setting of allergy and inflammation, has
the potential to result in broad inhibition of inflammatory cells.
In proliferative diseases like cancer, blocking an inhibitory
receptor can restore the immune system’s ability to identify and
kill proliferative cells. The Company’s most advanced antibodies
are lirentelimab (AK002) and AK006. Lirentelimab selectively
targets both mast cells and eosinophils, two types of white blood
cells that are widely distributed in the body and play a central
role in the inflammatory response. Inappropriately activated mast
cells and eosinophils have been identified as key drivers in a
number of severe diseases affecting the gastrointestinal tract,
eyes, skin, lungs and other organs. Allakos is developing
lirentelimab for the treatment of atopic dermatitis, chronic
spontaneous urticaria and potentially additional indications.
Lirentelimab has received orphan drug designations for eosinophilic
gastritis (EG), eosinophilic duodenitis (EoD), and eosinophilic
esophagitis (EoE) from the U.S. Food and Drug Administration. AK006
targets Siglec-6, an inhibitory receptor expressed selectively on
mast cells. In pre-clinical research, AK006 appears to provide
deeper mast cell inhibition than lirentelimab and, in addition to
its inhibitory activity, reduce mast cell numbers. Allakos plans to
begin human clinical trials with AK006 in the first half of 2023.
AK007 targets Siglec-10, a key inhibitory myeloid checkpoint
receptor that is selectively expressed on tumor associated
macrophages (TAMs) and dendritic cells (DCs). AK007 is designed to
block known ligand interaction with Siglec-10, including the “don’t
eat me” signal CD24. More recently, “don’t eat me” signals, such as
CD47 and CD24, have been identified to be overexpressed in tumors
and allow cancer cells to avoid destruction by macrophages and
other myeloid cells of the innate immune system. In pre-clinical
research, AK007 polarizes tumor-associated myeloid cells and
promotes anti-tumor immunity. Allakos is currently conducting
pre-clinical studies with AK007. 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, 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 initiation of a first-in-human study with
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 Allakos is targeting; Allakos’ ability
to advance additional product candidates beyond lirentelimab;
Allakos’ ability to obtain additional capital to finance its
operations, research and drug development; general economic and
market conditions, both domestic and international; domestic and
international regulatory obligations; and other risks. Information
regarding the foregoing and additional risks may be found in the
section entitled “Risk Factors” in documents that Allakos files
from time to time to 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, PresidentAlex Schwartz, VP
Strategic Finance and Investor Relationsir@allakos.com
Media Contact:Denise Powelldenise@redhousecomms.com
ALLAKOS INC. UNAUDITED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ |
33,078 |
|
|
$ |
176,807 |
|
General and administrative |
|
|
11,968 |
|
|
|
18,844 |
|
Total operating expenses |
|
|
45,046 |
|
|
|
195,651 |
|
Loss from operations |
|
|
(45,046 |
) |
|
|
(195,651 |
) |
Interest income |
|
|
2,678 |
|
|
|
83 |
|
Other expense, net |
|
|
(36 |
) |
|
|
(1,455 |
) |
Net loss |
|
|
(42,404 |
) |
|
|
(197,023 |
) |
Unrealized gain (loss) on investments |
|
|
296 |
|
|
|
(316 |
) |
Comprehensive loss |
|
$ |
(42,108 |
) |
|
$ |
(197,339 |
) |
Net loss per common share: |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(3.60 |
) |
Weighted-average number of common
shares outstanding: |
|
|
|
|
|
|
Basic and diluted |
|
|
85,845 |
|
|
|
54,686 |
|
ALLAKOS INC. UNAUDITED
CONDENSED BALANCE SHEETS (in
thousands)
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
93,854 |
|
|
$ |
87,217 |
|
Investments |
|
|
158,745 |
|
|
|
192,569 |
|
Prepaid expenses and other current assets |
|
|
30,261 |
|
|
|
29,057 |
|
Total current assets |
|
|
282,860 |
|
|
|
308,843 |
|
Property and equipment, net |
|
|
37,769 |
|
|
|
39,144 |
|
Operating lease right-of-use
assets |
|
|
24,798 |
|
|
|
30,225 |
|
Other long-term assets |
|
|
4,981 |
|
|
|
8,208 |
|
Total assets |
|
$ |
350,408 |
|
|
$ |
386,420 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
9,101 |
|
|
$ |
4,832 |
|
Accrued expenses and other current liabilities |
|
|
20,429 |
|
|
|
25,206 |
|
Total current liabilities |
|
|
29,530 |
|
|
|
30,038 |
|
Operating lease liabilities, net
of current portion |
|
|
40,430 |
|
|
|
45,949 |
|
Total liabilities |
|
|
69,960 |
|
|
|
75,987 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock |
|
|
86 |
|
|
|
85 |
|
Additional paid-in capital |
|
|
1,255,530 |
|
|
|
1,243,408 |
|
Accumulated other comprehensive gain (loss) |
|
|
12 |
|
|
|
(284 |
) |
Accumulated deficit |
|
|
(975,180 |
) |
|
|
(932,776 |
) |
Total stockholders’ equity |
|
|
280,448 |
|
|
|
310,433 |
|
Total liabilities and
stockholders’ equity |
|
$ |
350,408 |
|
|
$ |
386,420 |
|
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