- CTA-enabling work on track to seek approval to commence
Phase 1 clinical trial of LMNL6511 during the second half of
2023
- Addition of GPR40 agonist discovery program aiming for the
development of a novel liver-safe GPR40 agonist for the treatment
of type 2 diabetes
- Closed December 31, 2022 with
just over CAD 37 million cash on
hand, expecting to provide cash runway into early 2024
- Net loss from continuing operations of CAD 6.6 million during the quarter ended
December 31, 2022 compared to
CAD 8.8 million during the fourth
quarter of 2021
- Regained compliance with minimum bid price requirement for
continued listing on the Nasdaq Capital Market
- Completed the sale of a non-core real estate asset at the
end of December 2022, for a purchase price of CAD
3,175,000
- Strengthened the leadership team with the appointment of
Nicole Rusaw as Chief Financial
Officer and Dr. Gary Bridger as
Interim Chief Scientific Officer in 2022
LAVAL,
QC and CAMBRIDGE,
England, March 15, 2023 /PRNewswire/ - Liminal
BioSciences Inc. (NASDAQ: LMNL) ("Liminal BioSciences" or the
"Company"), a development-stage biopharmaceutical company focused
on discovering and developing distinctive novel small molecule
therapeutics for metabolic, inflammatory, and fibrotic diseases,
today reported its financial results for the fourth quarter and
fiscal year ended December 31,
2022.
"We begin 2023 in an exciting position, having met all our
previously disclosed milestones for our GPR84 and OXER1 antagonist
development programs. This includes the nomination of LMNL6511 as
the candidate selected for clinical development for our GPR84
antagonist program designed to treat metabolic diseases,
inflammation and/or fibrosis," stated Bruce
Pritchard, Chief Executive Officer of Liminal BioSciences.
"Work is also ongoing to select a lead candidate for our OXER1
antagonist program, targeting Eosinophil-driven disease. In
addition, we're pleased to announce today our GPR40 agonist
discovery program as the newest addition to our pipeline aiming to
identify and develop a liver-safe GPR40 agonist as a possible
treatment for type 2 diabetes. With this addition, we believe that
our development programs have the potential to provide us with
commercial opportunities in several metabolic, inflammatory and
fibrotic related therapeutic areas. At the core of our strategy is
our ability to advance our later-stage candidates with the intent
to develop and bring first-in-class medicines to patients,
supplementing this with our early-stage pipeline."
"Most importantly, we are continuing to leverage our drug
discovery platform and understanding of G protein-coupled
receptors to identify small molecule candidates that can
accurately target GPCRs", stated Dr. Gary
Bridger, Interim Chief Scientific Officer of Liminal
BioSciences. "Our drug discovery platform leverages fully
integrated chemistry and biology expertise supported by our broad
in-vivo capabilities which has allowed us to advance
our GPR84 antagonist development program. We plan to file for
authorization to commence a Phase 1 clinical trial with LMNL6511 in
the second half of 2023."
Key Priorities for 2023
GPR84 Antagonist Development Plan
- Subject to continued satisfactory results in ongoing clinical
trial application (CTA)-enabling work, we expect to seek approval
to commence a first-in-human Phase 1 clinical trial of LMNL6511
during the second half of 2023.
- On-going In-vivo experiments expected to allow us to
select a lead clinical indication in the coming months.
OXER1 Antagonist Development Plan
- Development of potential OXER-1 Antagonists is progressing
well, and we plan to nominate a lead candidate for further
development as a potential treatment for Eosinophilic mediated
diseases in H1 2023 and are aiming to commence a first-in-human
clinical trial in 2024.
GPR40 Agonist Development Plan
- Development of our GPR40 agonist program aiming to identify and
develop a novel liver-safe GPR40 agonist for the treatment of type
2 diabetes (T2D). Our GPR40 agonist development program is
currently at the discovery stage.
As we continue work on our development programs, we are
simultaneously assessing the commercial opportunities for all
assets. We believe that our GPR84 antagonist, OXER1 antagonist and
GPR40 agonist programs have the potential to address significant
unmet medical needs. In addition to these programs, we continue to
explore other development opportunities to add to our pipeline.
Recent Developments
- In November 2022, we announced
some changes to our executive leadership team. Nicole Rusaw, who had been serving as interim
Chief Financial Officer since March 2,
2022, was appointed as Chief Financial Officer, and Dr.
Gary Bridger, member of the Board of
Directors and Strategic Advisor to the Company, was named Interim
Chief Scientific Officer. Dr. Bridger continues to serve as a board
member of the Company.
- In December 2022, we completed
the sale of a non-core real estate asset, located in Pointe-Claire, Quebec, for a purchase price
of CAD 3,175,000.
- In February 2023, we completed a
consolidation of all the issued and outstanding common shares of
the Company on the basis of a consolidation ratio of ten (10)
pre-consolidation shares for one (1) post-consolidation share
to regain compliance with the minimum bid price requirement
for continued listing by achieving a closing bid price on Nasdaq
Capital Market of at least $1.00 per
share for a minimum of 10 consecutive trading days.
- In February 2023, we received
written notice from Nasdaq that the Company had regained compliance
with Nasdaq Listing Rule 5450(a)(1) for continued listing on the
Nasdaq Capital Market.
Fourth Quarter and Year Ended December
2022 Financial Results
All figures presented in this section are in Canadian
dollars.
- Cash and cash equivalents were $37.1 million at December
31, 2022 while our working capital, i.e., the current assets
net of current liabilities, was $31.2
million.
- Research and development expenses were $3.5 million during the fourth quarter of 2022
compared to $4.5 million for the
fourth quarter of 2021. The decrease of $1.1
million was mainly attributable to decreases in intangible
assets depreciation expense, clinical trial costs and professional
fees of $0.4 million, $0.5 million and $0.2
million respectively and a general reduction in operating
expenses. These decreases were partially offset by an increase in
pre-clinical trial costs of $0.4
million following the beginning of new pre-clinical studies
that took place in 2022.
- Administration expenses were $3.9 million for the fourth quarter of 2022
compared to $5.8 million for the
fourth quarter of 2021. The decrease in administration expenses was
mainly attributable to a decrease of $1.5
million in expense as a result of reduced directors' and
officers' insurance premiums resulting from the change in the
Company's registered office from Québec to Ontario in the later part of 2021, a reduction
in professional fees of $0.5 million
and a reduction in share-based payments expense of $0.3 million. These decreases were partially
offset by an increase in salaries and other benefits of
$0.7 million.
- Net loss from continuing operations, net of taxes was
$6.6 million for the fourth quarter
of 2022 compared to $8.8 million for
the fourth quarter of 2021. The decrease in loss was mainly driven
by the reductions in administration expenses of $1.9 million, reflecting the reduction in
insurance expense, a decrease in finance costs of $1.8 million due to the termination of all
long-term debt and a decrease in R&D expenses of $1.1 million.
- Total income (loss) from discontinued operations was an
income of $2.3 million for the fourth
quarter of 2022 compared to a loss of $0.6
million in the fourth quarter of 2021. The income from the
fourth quarter of 2022 comprised of the gain of $2.3 million on disposal of capital assets,
following the sale of a non-core real estate asset in December 2022, formerly part of the
plasma-derived therapeutics segment and previously classified as
property, plant and equipment, met the criteria to be classified as
held for sale during the quarter ended March
31, 2022 at a carrying amount of $0.8
million. As a result, we received $3.2 million in net proceeds from this sale.
- Net Loss was $4.2 million
for the fourth quarter of 2022 compared to income of $9.3 million for the fourth quarter of 2021.
About Liminal BioSciences Inc.
Liminal BioSciences is a development-stage biopharmaceutical
company focused on discovering and developing novel and distinctive
small molecule therapeutics that modulate G protein-coupled
receptor pathways (GPCRs). The Company is designing proprietary
novel small molecule therapeutic candidates with the intent of
developing best/first in class therapeutics for the treatment of
metabolic, inflammatory and fibrotic diseases with significant
unmet medical needs, using its integrated drug discovery platform,
medicinal chemistry expertise and deep understanding of GPCR
biology. The Company's pipeline is currently made up of three
programs. The candidate selected for clinical development,
LMNL6511, a selective antagonist for the GPR84 receptor, is
expected to commence a Phase 1 clinical trial in the second half of
2023. The Company is also developing potential OXER1 antagonists,
and GPR40 agonists, both of which are at the preclinical stage. In
addition to these programs, the Company continues to explore other
development opportunities to add to its pipeline.
Liminal BioSciences has active business operations in
Canada and the United Kingdom.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Some of the forward-looking statements can be identified
by the use of forward-looking words. Statements that are not
historical in nature, including the words "anticipate," "expect,"
"suggest," "plan," "believe," "intend," "estimate," "target,"
"project," "should," "could," "would," "may," "will," "forecast"
and other similar expressions are intended to identify
forward-looking statements. These statements include those related
to Liminal BioSciences' objectives, strategies and businesses that
involve risks and uncertainties. Forward–looking information
includes statements concerning, among other things: advancement of
Liminal Biosciences' candidates or development programs, including
the timing and outcome of the potential development of the
Company's R&D programs such as the development of LMNL6511 and
our GPR40 agonist and OXER1 antagonist discovery programs; the
timing of initiation or nature of preclinical and clinical trials,
including the expected commencement of a Phase 1 clinical trial of
LMNL6511 in the second half of 2023; the contemplated potential
therapeutic areas, including Eosinophilic mediated diseases and
T2D; the potential for our development programs to address
significant unmet medical needs; our ability to add new development
opportunities to our pipeline; our ability to continue to comply
with Nasdaq Listing Rule 5450(a)(1) to remain listed on the Nasdaq
Capital Market; our expected cash runway and our ability to
actively seek and close on opportunities to monetize non-core
assets or commercial opportunities related to our assets. These
statements are "forward-looking" because they are based on our
current expectations about the markets we operate in and on various
estimates and assumptions. Actual events or results may differ
materially from those anticipated in these forward-looking
statements if known or unknown risks affect our business, or if our
estimates or assumptions turn out to be inaccurate. Among the
factors that could cause actual results to differ materially from
those described or projected herein include, but are not limited
to, risks associated with: the Company's ability to develop,
manufacture, and successfully commercialize product candidates, if
ever; the impact of the COVID-19 pandemic and other geopolitical
tensions on the Company's workforce, business operations, clinical
development, regulatory activities and financial and other
corporate impacts; the availability of funds and resources to
pursue R&D projects, clinical development, manufacturing
operations or commercialization opportunities; the successful and
timely initiation or completion of preclinical and clinical trials;
the ability to take advantage of financing opportunities or
business opportunities in the pharmaceutical
industry, uncertainties associated generally with research and
development, clinical trials and related regulatory reviews and
approvals; our ability to comply with Nasdaq listing rules and
remain listed on the Nasdaq Capital Market and general changes in
economic conditions, including as a result of increased inflation,
bank failures and rising interest rates. You will find a more
detailed assessment of these risks, uncertainties and other risks
that could cause actual events or results to materially differ from
our current expectations in the filings and reports the Company
makes with the U.S. Securities and Exchange Commission and Canadian
Securities Administrators, including in the Annual Report on Form
20-F for the year ended December 31,
2022, as well as other filings and reports Liminal
Biosciences' may make from time to time. As a result, we cannot
guarantee that any given forward-looking statement will
materialize. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements and
estimates, which speak only as of the date hereof. We assume no
obligation to update any forward-looking statement contained in
this press release even if new information becomes available, as a
result of future events or for any other reason, unless required by
applicable securities laws and regulations.
View original
content:https://www.prnewswire.com/news-releases/liminal-biosciences-reports-fourth-quarter-and-year-ended-2022-financial-results-301773355.html
SOURCE Liminal BioSciences Inc.